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测试将抗癌药物伊立替康加入晚期直肠癌长期放疗后的标准化疗治疗 (FOLFOX) 以提高完全缓解率和长期器官保存率 (JANUS)

2026年9月23日 更新者：Alliance for Clinical Trials in Oncology

Janus 直肠癌试验：一项随机 II 期试验，测试三联化疗与双联化疗对局部晚期直肠癌患者实现临床完全缓解的疗效

This phase II/III trial compares the effect of usual treatment approach alone (FOLFOX or CAPOX after chemoradiation) with using FOLFIRINOX after chemoradiation in patients with stage II-III rectal cancer. Combination chemotherapy regimens, such as FOLFIRINOX (folinic acid (leucovorin), fluorouracil, irinotecan, and oxaliplatin), FOLFOX (leucovorin, fluorouracil, and oxaliplatin), or CAPOX (capecitabine and oxaliplatin) use more than one anticancer drug that work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. FOLFOX or CAPOX are used after chemoradiation as usual treatment for rectal cancer. Giving FOLFIRINOX after chemoradiation may increase the response rate for the primary rectal tumor and lead to higher rates of clinical complete response (and thus a chance to avoid surgery) compared to FOLFOX or CAPOX after chemoradiation in patients with locally advanced rectal cancer.

研究概览

地位

主动，不招人

条件

干预/治疗

详细说明

PRIMARY OBJECTIVES:

I. To evaluate and compare the clinical complete response (cCR) rates in patients with locally advanced rectal cancer treated with neoadjuvant long-course radiotherapy (LCRT) followed by neoadjuvant modified leucovorin fluorouracil, irinotecan, and oxaliplatin (mFOLFIRINOX) versus neoadjuvant LCRT followed by neoadjuvant modified leucovorin , fluorouracil, and oxaliplatin (mFOLFOX6)/CAPOX (Phase II).

II. To evaluate and compare disease-free survival (DFS) in patients with locally advanced rectal cancer treated with neoadjuvant LCRT followed by neoadjuvant mFOLFIRINOX versus neoadjuvant LCRT followed by neoadjuvant mFOLFOX6/CAPOX. (Phase III)

SECONDARY OBJECTIVES:

I. To evaluate and compare organ-preservation-time (OPT) between two treatment arms.

II. To evaluate and compare time to distant metastasis between two treatment arms.

III. To evaluate and compare overall survival (OS) between two treatment arms. IV. To evaluate and compare toxicity profiles of total neoadjuvant therapy (TNT) between two treatment arms.

V. To evaluate and compare sustained cCR between two treatment arms.

EXPLORATORY OBJECTIVE:

I. Evaluation of circulating tumor deoxyribonucleic acid (ctDNA) kinetics during neoadjuvant therapy & surveillance and to correlate with radiographic, pathologic, and clinical outcomes.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I:

LCRT: Patients undergo long-course chemoradiation therapy for up to 5 weeks. CONSOLIDATION: Patients receive either FOLFOX (consisting of leucovorin IV over 2 hours on day 1 of each cycle, fluorouracil IV bolus over 2-4 minutes and IV continuous infusion over 46-48 hours on day 1 of each cycle, and oxaliplatin IV over 2 hours on day 1 of each cycle or CAPOX consisting of capecitabine orally on days 1-14 of each cycle, and oxaliplatin IV over 2 hours on day 1 of each cycle. Treatment with FOLFOX repeats every 2 weeks for up to 8 cycles (16 weeks) in the absence of disease progression or unacceptable toxicity. Treatment with CAPOX repeats every 3 weeks for up to 5 cycles (15 weeks) in the absence of disease progression or unacceptable toxicity.

ARM II:

LCRT: Patients undergo long course chemoradiation therapy for up to 5 weeks. CONSOLIDATION: Patients receive FOLFIRINOX (consisting of leucovorin IV over 2 hours on day 1 of each cycle, fluorouracil IV continuous infusion over 46-48 hours on day 1 of each cycle, oxaliplatin IV over 2 hours on day 1 of each cycle, and irinotecan IV over 30-90 minutes on day 1 of each cycle) Treatment with FOLFIRINOX repeats every 2 weeks for up to 8 cycles (16 weeks) in the absence of disease progression or unacceptable toxicity.

All patients undergo CT scan, MRI scan, and collection of blood samples, and sigmoidoscopy throughout the trial and undergo biopsy during screening.

研究类型

介入性

注册 (实际的)

760

阶段

  • 阶段2
  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 波多黎各
      • Bayamón、波多黎各、00959-5060
        • Cancer Center-Metro Medical Center Bayamon
      • Manati、波多黎各、00674
        • Doctors Cancer Center
      • San Juan、波多黎各、00917
        • San Juan Community Oncology Group
      • San Juan、波多黎各、00927
        • Centro Comprensivo de Cancer de UPR
      • San Juan、波多黎各、00936
        • San Juan City Hospital
      • San Juan、波多黎各、00902
        • Pan American Center for Oncology Trials LLC
  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35233
        • University of Alabama at Birmingham Cancer Center
      • Mobile、Alabama、美国、36688
        • University of South Alabama Mitchell Cancer Institute
    • Alaska
      • Anchorage、Alaska、美国、98508
        • Anchorage Associates in Radiation Medicine
      • Anchorage、Alaska、美国、99508
        • Alaska Breast Care and Surgery LLC
      • Anchorage、Alaska、美国、99508
        • Alaska Oncology and Hematology LLC
      • Anchorage、Alaska、美国、99508
        • Alaska Women's Cancer Care
      • Anchorage、Alaska、美国、99508
        • Anchorage Oncology Centre
      • Anchorage、Alaska、美国、99508
        • Katmai Oncology Group
      • Anchorage、Alaska、美国、99508
        • Providence Alaska Medical Center
    • Arizona
      • Kingman、Arizona、美国、86401
        • Kingman Regional Medical Center
      • Phoenix、Arizona、美国、85054
        • Mayo Clinic Hospital in Arizona
      • Phoenix、Arizona、美国、85004
        • Cancer Center at Saint Joseph's
    • Arkansas
      • Fort Smith、Arkansas、美国、72903
        • Mercy Hospital Fort Smith
      • Jonesboro、Arkansas、美国、72401
        • NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
      • Little Rock、Arkansas、美国、72205
        • University of Arkansas for Medical Sciences
    • California
      • Arroyo Grande、California、美国、93420
        • PCR Oncology
      • Arroyo Grande、California、美国、93420
        • Mission Hope Medical Oncology - Arroyo Grande
      • Buena Park、California、美国、90621
        • Keck Medicine of USC Buena Park
      • Burbank、California、美国、91505
        • Providence Saint Joseph Medical Center/Disney Family Cancer Center
      • Carmichael、California、美国、95608
        • Mercy San Juan Medical Center
      • Carmichael、California、美国、95608
        • Mercy Cancer Center - Carmichael
      • Duarte、California、美国、91010
        • City of Hope Comprehensive Cancer Center
      • Elk Grove、California、美国、95758
        • Mercy Cancer Center - Elk Grove
      • Fremont、California、美国、94538
        • Washington Hospital
      • Irvine、California、美国、92618
        • City of Hope at Irvine Lennar
      • Irvine、California、美国、92612
        • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
      • Los Angeles、California、美国、90033
        • USC / Norris Comprehensive Cancer Center
      • Los Angeles、California、美国、90033
        • Los Angeles General Medical Center
      • Merced、California、美国、95340
        • Mercy Cancer Center
      • Napa、California、美国、94558
        • Providence Queen of The Valley
      • Newport Beach、California、美国、92663
        • USC Norris Oncology/Hematology-Newport Beach
      • Orange、California、美国、92868
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
      • Orange、California、美国、92868
        • Saint Joseph Hospital - Orange
      • Rocklin、California、美国、95765
        • Mercy Cancer Center - Rocklin
      • Sacramento、California、美国、95817
        • University of California Davis Comprehensive Cancer Center
      • Sacramento、California、美国、95816
        • Mercy Cancer Center - Sacramento
      • Salinas、California、美国、93901
        • Salinas Valley Memorial
      • San Luis Obispo、California、美国、93401
        • Pacific Central Coast Health Center-San Luis Obispo
      • Santa Maria、California、美国、93444
        • Mission Hope Medical Oncology - Santa Maria
      • Santa Rosa、California、美国、95403
        • Providence Medical Foundation - Santa Rosa
      • South Pasadena、California、美国、91030
        • City of Hope South Pasadena
      • St. Helena、California、美国、94574
        • Saint Helena Hospital
      • Stockton、California、美国、95204
        • Saint Joseph's Medical Center
      • Torrance、California、美国、90503
        • City of Hope South Bay
      • Truckee、California、美国、96161
        • Gene Upshaw Memorial Tahoe Forest Cancer Center
      • Upland、California、美国、91786
        • City of Hope Upland
      • Walnut Creek、California、美国、94598
        • John Muir Medical Center-Walnut Creek
      • Woodland、California、美国、95695
        • Woodland Memorial Hospital
    • Colorado
      • Aurora、Colorado、美国、80045
        • UCHealth University of Colorado Hospital
      • Colorado Springs、Colorado、美国、80907
        • Penrose-Saint Francis Healthcare
      • Colorado Springs、Colorado、美国、80909
        • UCHealth Memorial Hospital Central
      • Colorado Springs、Colorado、美国、80907
        • Rocky Mountain Cancer Centers-Penrose
      • Colorado Springs、Colorado、美国、80920
        • Memorial Hospital North
      • Colorado Springs、Colorado、美国、80923
        • Saint Francis Cancer Center
      • Denver、Colorado、美国、80206
        • UCHealth - Cherry Creek
      • Denver、Colorado、美国、80218
        • Saint Joseph Hospital - Cancer Centers of Colorado
      • Denver、Colorado、美国、80210
        • AdventHealth Porter
      • Golden、Colorado、美国、80401
        • Lutheran Hospital - Cancer Centers of Colorado
      • Grand Junction、Colorado、美国、81501
        • Saint Mary's Hospital and Regional Medical Center
      • Highlands Ranch、Colorado、美国、80129
        • UCHealth Highlands Ranch Hospital
      • Lakewood、Colorado、美国、80228
        • Saint Anthony Hospital
      • Littleton、Colorado、美国、80122
        • AdventHealth Littleton
      • Longmont、Colorado、美国、80501
        • Longmont United Hospital
      • Parker、Colorado、美国、80138
        • AdventHealth Parker
      • Pueblo、Colorado、美国、81004
        • Saint Mary Corwin Medical Center
      • Westminster、Colorado、美国、80023
        • Saint Anthony North Hospital
      • Wheat Ridge、Colorado、美国、80401
        • Intermountain Health Lutheran Hospital
    • Connecticut
      • Hartford、Connecticut、美国、06102
        • Hartford Hospital
      • Meriden、Connecticut、美国、06451
        • Midstate Medical Center
      • New Britain、Connecticut、美国、06050
        • The Hospital of Central Connecticut
    • Delaware
      • Lewes、Delaware、美国、19958
        • Beebe Medical Center
      • Millville、Delaware、美国、19967
        • Beebe South Coastal Health Campus
      • Newark、Delaware、美国、19713
        • Helen F Graham Cancer Center
      • Newark、Delaware、美国、19713
        • Delaware Clinical and Laboratory Physicians PA
      • Newark、Delaware、美国、19713
        • Medical Oncology Hematology Consultants PA
      • Newark、Delaware、美国、19718
        • Christiana Care Health System-Christiana Hospital
      • Rehoboth Beach、Delaware、美国、19971
        • Beebe Health Campus
      • Wilmington、Delaware、美国、19801
        • Christiana Care Health System-Wilmington Hospital
    • District of Columbia
      • Washington D.C.、District of Columbia、美国、20037
        • George Washington University Medical Center
      • Washington D.C.、District of Columbia、美国、20010
        • MedStar Washington Hospital Center
      • Washington D.C.、District of Columbia、美国、20007
        • MedStar Georgetown University Hospital
    • Florida
      • Altamonte Springs、Florida、美国、32701
        • AdventHealth Altamonte
      • Aventura、Florida、美国、33180
        • Mount Sinai Comprehensive Cancer Center at Aventura
      • Celebration、Florida、美国、34747
        • AdventHealth Celebration
      • Clearwater、Florida、美国、33756
        • Morton Plant Hospital
      • Fort Lauderdale、Florida、美国、33308
        • Holy Cross Hospital
      • Gainesville、Florida、美国、32610
        • University of Florida Health Science Center - Gainesville
      • Hollywood、Florida、美国、33021
        • Memorial Regional Hospital/Joe DiMaggio Children's Hospital
      • Jacksonville、Florida、美国、32224-9980
        • Mayo Clinic in Florida
      • Kissimmee、Florida、美国、34744
        • AdventHealth Kissimmee
      • Lutz、Florida、美国、33558
        • Saint Joseph's Hospital-North
      • Miami Beach、Florida、美国、33140
        • Mount Sinai Medical Center
      • Orlando、Florida、美国、32803
        • AdventHealth Orlando
      • Orlando、Florida、美国、32822
        • AdventHealth East Orlando
      • Pembroke Pines、Florida、美国、33028
        • Memorial Hospital West
      • St. Petersburg、Florida、美国、33705
        • Saint Anthony's Hospital Cancer Care Center
      • Tampa、Florida、美国、33606
        • Tampa General Hospital
      • Tampa、Florida、美国、33607
        • Saint Joseph's Hospital/Children's Hospital-Tampa
    • Georgia
      • Atlanta、Georgia、美国、30308
        • Emory University Hospital Midtown
      • Atlanta、Georgia、美国、30322
        • Emory University Hospital/Winship Cancer Institute
      • Atlanta、Georgia、美国、30342
        • Emory Saint Joseph's Hospital
      • Decatur、Georgia、美国、30033
        • Emory Decatur Hospital
      • Johns Creek、Georgia、美国、30097
        • Emory Johns Creek Hospital
      • Savannah、Georgia、美国、31404
        • Memorial Health University Medical Center
    • Hawaii
      • Honolulu、Hawaii、美国、96813
        • Queen's Medical Center
      • Honolulu、Hawaii、美国、96817
        • The Cancer Center of Hawaii-Liliha
      • Honolulu、Hawaii、美国、96813
        • Hawaii Cancer Care Inc - Waterfront Plaza
      • Honolulu、Hawaii、美国、96813
        • Queen's Cancer Cenrer - POB I
      • Honolulu、Hawaii、美国、96813
        • Straub Clinic and Hospital
      • Honolulu、Hawaii、美国、96813
        • University of Hawaii Cancer Center
      • Honolulu、Hawaii、美国、96817
        • Kuakini Medical Center
      • Honolulu、Hawaii、美国、96817
        • Queen's Cancer Center - Kuakini
      • Honolulu、Hawaii、美国、96826
        • Kapiolani Medical Center for Women and Children
      • Kailua、Hawaii、美国、96734
        • Castle Medical Center
      • Lihue、Hawaii、美国、96766
        • Wilcox Memorial Hospital and Kauai Medical Clinic
      • ‘Aiea、Hawaii、美国、96701
        • Hawaii Cancer Care - Westridge
      • ‘Aiea、Hawaii、美国、96701
        • Pali Momi Medical Center
      • ‘Aiea、Hawaii、美国、96701
        • Queen's Cancer Center - Pearlridge
      • ‘Aiea、Hawaii、美国、96701
        • The Cancer Center of Hawaii-Pali Momi
      • ‘Ewa Beach、Hawaii、美国、96706
        • The Queen's Medical Center - West Oahu
    • Idaho
      • Boise、Idaho、美国、83706
        • Saint Alphonsus Cancer Care Center-Boise
      • Boise、Idaho、美国、83712
        • Saint Luke's Cancer Institute - Boise
      • Caldwell、Idaho、美国、83605
        • Saint Alphonsus Cancer Care Center-Caldwell
      • Coeur d'Alene、Idaho、美国、83814
        • Kootenai Health - Coeur d'Alene
      • Fruitland、Idaho、美国、83619
        • Saint Luke's Cancer Institute - Fruitland
      • Meridian、Idaho、美国、83642
        • Idaho Urologic Institute-Meridian
      • Meridian、Idaho、美国、83642
        • Saint Luke's Cancer Institute - Meridian
      • Nampa、Idaho、美国、83687
        • Saint Alphonsus Cancer Care Center-Nampa
      • Nampa、Idaho、美国、83687
        • Saint Luke's Cancer Institute - Nampa
      • Post Falls、Idaho、美国、83854
        • Kootenai Clinic Cancer Services - Post Falls
      • Twin Falls、Idaho、美国、83301
        • Saint Luke's Cancer Institute - Twin Falls
    • Illinois
      • Alton、Illinois、美国、62002
        • OSF Saint Anthony's Health Center
      • Aurora、Illinois、美国、60504
        • Rush-Copley Medical Center
      • Aurora、Illinois、美国、60506
        • Advocate Outpatient Center - Aurora
      • Barrington、Illinois、美国、60010
        • Advocate Good Shepherd Hospital
      • Bloomington、Illinois、美国、61704
        • Illinois CancerCare-Bloomington
      • Bloomington、Illinois、美国、61701
        • OSF Saint Joseph Medical Center
      • Canton、Illinois、美国、61520
        • Illinois CancerCare-Canton
      • Carbondale、Illinois、美国、62902
        • Memorial Hospital of Carbondale
      • Carterville、Illinois、美国、62918
        • SIH Cancer Institute
      • Carthage、Illinois、美国、62321
        • Illinois CancerCare-Carthage
      • Centralia、Illinois、美国、62801
        • Centralia Oncology Clinic
      • Centralia、Illinois、美国、62801
        • Saint Mary's Hospital
      • Chicago、Illinois、美国、60611
        • Northwestern University
      • Chicago、Illinois、美国、60637
        • University of Chicago Comprehensive Cancer Center
      • Chicago、Illinois、美国、60612
        • John H Stroger Jr Hospital of Cook County
      • Chicago、Illinois、美国、60657
        • Advocate Illinois Masonic Medical Center
      • Crystal Lake、Illinois、美国、60014
        • AMG Crystal Lake - Oncology
      • Danville、Illinois、美国、61832
        • Carle at The Riverfront
      • DeKalb、Illinois、美国、60115
        • Northwestern Medicine Cancer Center Kishwaukee
      • Decatur、Illinois、美国、62526
        • Decatur Memorial Hospital
      • Decatur、Illinois、美国、62526
        • Cancer Care Specialists of Illinois - Decatur
      • Dixon、Illinois、美国、61021
        • Illinois CancerCare-Dixon
      • Downers Grove、Illinois、美国、60515
        • Advocate Good Samaritan Hospital
      • Effingham、Illinois、美国、62401
        • Crossroads Cancer Center
      • Effingham、Illinois、美国、62401
        • Carle Physician Group-Effingham
      • Elgin、Illinois、美国、60123
        • Advocate Sherman Hospital
      • Elmhurst、Illinois、美国、60126
        • Elmhurst Memorial Hospital
      • Eureka、Illinois、美国、61530
        • Illinois CancerCare-Eureka
      • Galesburg、Illinois、美国、61401
        • Western Illinois Cancer Treatment Center
      • Galesburg、Illinois、美国、61401
        • Illinois CancerCare-Galesburg
      • Geneva、Illinois、美国、60134
        • Northwestern Medicine Cancer Center Delnor
      • Glenview、Illinois、美国、60026
        • Northwestern Medicine Glenview Outpatient Center
      • Grayslake、Illinois、美国、60030
        • Northwestern Medicine Grayslake Outpatient Center
      • Harvey、Illinois、美国、60426
        • Ingalls Memorial Hospital
      • Hazel Crest、Illinois、美国、60429
        • Advocate South Suburban Hospital
      • Kewanee、Illinois、美国、61443
        • Illinois CancerCare-Kewanee Clinic
      • Lake Forest、Illinois、美国、60045
        • Northwestern Medicine Lake Forest Hospital
      • Libertyville、Illinois、美国、60048
        • Condell Memorial Hospital
      • Libertyville、Illinois、美国、60048
        • AMG Libertyville - Oncology
      • Macomb、Illinois、美国、61455
        • Illinois CancerCare-Macomb
      • Mattoon、Illinois、美国、61938
        • Carle Physician Group-Mattoon/Charleston
      • Mount Vernon、Illinois、美国、62864
        • SSM Health Good Samaritan
      • Naperville、Illinois、美国、60540
        • Edward Hospital/Cancer Center
      • New Lenox、Illinois、美国、60451
        • UC Comprehensive Cancer Center at Silver Cross
      • Normal、Illinois、美国、61761
        • Carle Cancer Institute Normal
      • Normal、Illinois、美国、61761
        • Carle BroMenn Medical Center
      • O'Fallon、Illinois、美国、62269
        • Cancer Care Center of O'Fallon
      • O'Fallon、Illinois、美国、62269
        • HSHS Saint Elizabeth's Hospital
      • Oak Lawn、Illinois、美国、60453-2699
        • Advocate Christ Medical Center
      • Orland Park、Illinois、美国、60462
        • University of Chicago Medicine-Orland Park
      • Ottawa、Illinois、美国、61350
        • Illinois CancerCare-Ottawa Clinic
      • Palos Heights、Illinois、美国、60463
        • Advocate High Tech Medical Park
      • Park Ridge、Illinois、美国、60068
        • Advocate Lutheran General Hospital
      • Pekin、Illinois、美国、61554
        • Illinois CancerCare-Pekin
      • Peoria、Illinois、美国、61636
        • Methodist Medical Center of Illinois
      • Peoria、Illinois、美国、61615
        • Illinois CancerCare-Peoria
      • Peru、Illinois、美国、61354
        • Illinois CancerCare-Peru
      • Peru、Illinois、美国、61354
        • Valley Radiation Oncology
      • Plainfield、Illinois、美国、60585
        • Edward Hospital/Cancer Center?Plainfield
      • Princeton、Illinois、美国、61356
        • Illinois CancerCare-Princeton
      • Springfield、Illinois、美国、62702
        • Southern Illinois University School of Medicine
      • Springfield、Illinois、美国、62702
        • Springfield Clinic
      • Springfield、Illinois、美国、62781
        • Springfield Memorial Hospital
      • Urbana、Illinois、美国、61801
        • Carle Cancer Center
      • Warrenville、Illinois、美国、60555
        • Northwestern Medicine Cancer Center Warrenville
      • Washington、Illinois、美国、61571
        • Illinois CancerCare - Washington
    • Indiana
      • Crown Point、Indiana、美国、46307
        • Northwest Cancer Center - Main Campus
      • Dyer、Indiana、美国、46311
        • Northwest Oncology LLC
      • Fort Wayne、Indiana、美国、46845
        • Parkview Regional Medical Center
      • Hobart、Indiana、美国、46342
        • Northwest Cancer Center - Hobart
      • Hobart、Indiana、美国、46342
        • Saint Mary Medical Center
      • Munster、Indiana、美国、46321
        • The Community Hospital
      • Munster、Indiana、美国、46321
        • Women's Diagnostic Center - Munster
      • New Albany、Indiana、美国、47150
        • Baptist Health Floyd
      • Richmond、Indiana、美国、47374
        • Reid Health
      • Valparaiso、Indiana、美国、46383
        • Northwest Cancer Center - Valparaiso
    • Iowa
      • Ankeny、Iowa、美国、50023
        • UI Health Care Mission Cancer and Blood - Ankeny Clinic
      • Cedar Rapids、Iowa、美国、52403
        • Mercy Hospital
      • Cedar Rapids、Iowa、美国、52403
        • Oncology Associates at Mercy Medical Center
      • Clive、Iowa、美国、50325
        • Mercy Cancer Center-West Lakes
      • Clive、Iowa、美国、50325
        • UI Health Care Mission Cancer and Blood - West Des Moines Clinic
      • Creston、Iowa、美国、50801
        • Greater Regional Medical Center
      • Des Moines、Iowa、美国、50309
        • Iowa Methodist Medical Center
      • Des Moines、Iowa、美国、50314
        • Mercy Medical Center - Des Moines
      • Des Moines、Iowa、美国、50309
        • UI Health Care Mission Cancer and Blood - Des Moines Clinic
      • Des Moines、Iowa、美国、50314
        • UI Health Care Mission Cancer and Blood - Laurel Clinic
      • Waukee、Iowa、美国、50263
        • UI Health Care Mission Cancer and Blood - Waukee Clinic
      • West Des Moines、Iowa、美国、50266
        • Mercy Medical Center-West Lakes
    • Kansas
      • Garden City、Kansas、美国、67846
        • Central Care Cancer Center - Garden City
      • Great Bend、Kansas、美国、67530
        • Central Care Cancer Center - Great Bend
    • Kentucky
      • Corbin、Kentucky、美国、40701
        • Baptist Health Corbin
      • Edgewood、Kentucky、美国、41017
        • Saint Elizabeth Healthcare Edgewood
      • Fort Thomas、Kentucky、美国、41075
        • Saint Elizabeth Healthcare Fort Thomas
      • Lexington、Kentucky、美国、40536
        • University of Kentucky/Markey Cancer Center
      • Lexington、Kentucky、美国、40504
        • Saint Joseph Radiation Oncology Resource Center
      • Lexington、Kentucky、美国、40509
        • Saint Joseph Hospital East
      • Lexington、Kentucky、美国、40503
        • Baptist Health Lexington
      • Lexington、Kentucky、美国、40504
        • Saint Joseph Hospital
      • Lexington、Kentucky、美国、40509
        • Baptist Health Hamburg
      • Louisville、Kentucky、美国、40202
        • The James Graham Brown Cancer Center at University of Louisville
      • Louisville、Kentucky、美国、40245
        • UofL Health Medical Center Northeast
      • Louisville、Kentucky、美国、40207
        • Baptist Health Louisville
      • Paducah、Kentucky、美国、42003
        • Baptist Health Paducah
    • Louisiana
      • Covington、Louisiana、美国、70433
        • Ochsner Hematology Oncology North Shore - Covington (West Region)
      • New Orleans、Louisiana、美国、70121
        • Ochsner Medical Center Jefferson
      • New Orleans、Louisiana、美国、70112
        • University Medical Center New Orleans
    • Maine
      • Brewer、Maine、美国、04412
        • Lafayette Family Cancer Center-EMMC
    • Maryland
      • Baltimore、Maryland、美国、21237
        • MedStar Franklin Square Medical Center/Weinberg Cancer Institute
      • Baltimore、Maryland、美国、21215
        • Sinai Hospital of Baltimore
      • Baltimore、Maryland、美国、21239
        • MedStar Good Samaritan Hospital
      • Cumberland、Maryland、美国、21502
        • UPMC Western Maryland
      • Westminster、Maryland、美国、21157
        • William E Kahlert Regional Cancer Center/Sinai Hospital
    • Massachusetts
      • Boston、Massachusetts、美国、02215
        • Beth Israel Deaconess Medical Center
      • Boston、Massachusetts、美国、02215
        • Dana-Farber Cancer Institute
      • Boston、Massachusetts、美国、02118
        • Boston Medical Center
      • Burlington、Massachusetts、美国、01805
        • Lahey Hospital and Medical Center
      • Foxborough、Massachusetts、美国、02035
        • Dana-Farber Cancer Institute at Foxborough
      • Methuen、Massachusetts、美国、01844
        • Dana Farber-Merrimack Valley
      • Milford、Massachusetts、美国、01757
        • Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
      • Peabody、Massachusetts、美国、01960
        • Lahey Medical Center-Peabody
      • South Weymouth、Massachusetts、美国、02190
        • Dana-Farber/Brigham and Women's Cancer Center at South Shore
    • Michigan
      • Ann Arbor、Michigan、美国、48106
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
      • Ann Arbor、Michigan、美国、48109
        • University of Michigan Comprehensive Cancer Center
      • Brighton、Michigan、美国、48114
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
      • Brighton、Michigan、美国、48116
        • University of Michigan - Brighton Center for Specialty Care
      • Brighton、Michigan、美国、48114
        • Trinity Health Medical Center - Brighton
      • Brownstown、Michigan、美国、48183
        • Henry Ford Cancer Institute-Downriver
      • Canton、Michigan、美国、48188
        • Trinity Health IHA Medical Group Hematology Oncology - Canton
      • Canton、Michigan、美国、48188
        • Trinity Health Medical Center - Canton
      • Caro、Michigan、美国、48723
        • Caro Cancer Center
      • Chelsea、Michigan、美国、48118
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
      • Chelsea、Michigan、美国、48118
        • Chelsea Hospital
      • Clinton Township、Michigan、美国、48038
        • Henry Ford Macomb Hospital-Clinton Township
      • Dearborn、Michigan、美国、48124
        • Corewell Health Dearborn Hospital
      • Detroit、Michigan、美国、48202
        • Henry Ford Hospital
      • Detroit、Michigan、美国、48236
        • Henry Ford Health Saint John Hospital
      • Farmington Hills、Michigan、美国、48336
        • Corewell Health Farmington Hills Hospital
      • Flint、Michigan、美国、48503
        • Hurley Medical Center
      • Flint、Michigan、美国、48503
        • Genesys Hurley Cancer Institute
      • Grosse Pointe Woods、Michigan、美国、48236
        • Henry Ford Saint John Hospital - Van Elslander
      • Jackson、Michigan、美国、49201
        • Allegiance Health
      • Lansing、Michigan、美国、48912
        • University of Michigan Health - Sparrow Lansing
      • Livonia、Michigan、美国、48154
        • Trinity Health Saint Mary Mercy Livonia Hospital
      • Macomb、Michigan、美国、48044
        • Henry Ford Saint John Hospital - Macomb Medical
      • Marlette、Michigan、美国、48453
        • Saint Mary's Oncology/Hematology Associates of Marlette
      • Midland、Michigan、美国、48670
        • MyMichigan Medical Center Midland
      • Novi、Michigan、美国、48377
        • Henry Ford Medical Center-Columbus
      • Novi、Michigan、美国、48374
        • Henry Ford Health Providence Novi Hospital
      • Pontiac、Michigan、美国、48341
        • Trinity Health Saint Joseph Mercy Oakland Hospital
      • Pontiac、Michigan、美国、48341
        • Michigan Healthcare Professionals Pontiac
      • Royal Oak、Michigan、美国、48073
        • Corewell Health William Beaumont University Hospital
      • Saginaw、Michigan、美国、48604
        • Oncology Hematology Associates of Saginaw Valley PC
      • Saginaw、Michigan、美国、48601
        • MyMichigan Medical Center Saginaw
      • Southfield、Michigan、美国、48075
        • Henry Ford Health Providence Southfield Hospital
      • Tawas City、Michigan、美国、48764
        • MyMichigan Medical Center Tawas
      • Troy、Michigan、美国、48085
        • Corewell Health Beaumont Troy Hospital
      • Warren、Michigan、美国、48093
        • Henry Ford Health Warren Hospital
      • West Bloomfield、Michigan、美国、48322
        • Henry Ford West Bloomfield Hospital
      • West Branch、Michigan、美国、48661
        • Saint Mary's Oncology/Hematology Associates of West Branch
      • Ypsilanti、Michigan、美国、48197
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
    • Minnesota
      • Bemidji、Minnesota、美国、56601
        • Sanford Joe Lueken Cancer Center
      • Brainerd、Minnesota、美国、56401
        • Essentia Health Saint Joseph's Medical Center
      • Burnsville、Minnesota、美国、55337
        • Minnesota Oncology - Burnsville
      • Coon Rapids、Minnesota、美国、55433
        • Mercy Hospital
      • Deer River、Minnesota、美国、56636
        • Essentia Health - Deer River Clinic
      • Detroit Lakes、Minnesota、美国、56501
        • Essentia Health Saint Mary's - Detroit Lakes Clinic
      • Duluth、Minnesota、美国、55805
        • Essentia Health Cancer Center
      • Duluth、Minnesota、美国、55805
        • Essentia Health Saint Mary's Medical Center
      • Duluth、Minnesota、美国、55805
        • Miller-Dwan Hospital
      • Edina、Minnesota、美国、55435
        • Fairview Southdale Hospital
      • Fosston、Minnesota、美国、56542
        • Essentia Health - Fosston
      • Hibbing、Minnesota、美国、55746
        • Essentia Health Hibbing Clinic
      • Maple Grove、Minnesota、美国、55369
        • Fairview Clinics and Surgery Center Maple Grove
      • Maplewood、Minnesota、美国、55109
        • Saint John's Hospital - Healtheast
      • Maplewood、Minnesota、美国、55109
        • Minnesota Oncology Hematology PA-Maplewood
      • Minneapolis、Minnesota、美国、55415
        • Hennepin County Medical Center
      • Minneapolis、Minnesota、美国、55407
        • Abbott-Northwestern Hospital
      • Minneapolis、Minnesota、美国、55454
        • Health Partners Inc
      • Monticello、Minnesota、美国、55362
        • Monticello Cancer Center
      • Park Rapids、Minnesota、美国、56470
        • Essentia Health - Park Rapids
      • Robbinsdale、Minnesota、美国、55422
        • North Memorial Medical Health Center
      • Rochester、Minnesota、美国、55905
        • Mayo Clinic in Rochester
      • Saint Cloud、Minnesota、美国、56303
        • Coborn Cancer Center at Saint Cloud Hospital
      • Saint Louis Park、Minnesota、美国、55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Paul、Minnesota、美国、55101
        • Regions Hospital
      • Saint Paul、Minnesota、美国、55102
        • United Hospital
      • Sandstone、Minnesota、美国、55072
        • Essentia Health Sandstone
      • Shakopee、Minnesota、美国、55379
        • Saint Francis Regional Medical Center
      • Stillwater、Minnesota、美国、55082
        • Lakeview Hospital
      • Virginia、Minnesota、美国、55792
        • Essentia Health Virginia Clinic
      • Waconia、Minnesota、美国、55387
        • Ridgeview Medical Center
      • Willmar、Minnesota、美国、56201
        • Rice Memorial Hospital
      • Woodbury、Minnesota、美国、55125
        • Minnesota Oncology Hematology PA-Woodbury
    • Mississippi
      • Columbus、Mississippi、美国、39705
        • Baptist Memorial Hospital and Cancer Center-Golden Triangle
      • Grenada、Mississippi、美国、38901
        • Baptist Cancer Center-Grenada
      • New Albany、Mississippi、美国、38652
        • Baptist Memorial Hospital and Cancer Center-Union County
      • Oxford、Mississippi、美国、38655
        • Baptist Memorial Hospital and Cancer Center-Oxford
      • Southhaven、Mississippi、美国、38671
        • Baptist Memorial Hospital and Cancer Center-Desoto
    • Missouri
      • Bolivar、Missouri、美国、65613
        • Central Care Cancer Center - Bolivar
      • Cape Girardeau、Missouri、美国、63703
        • Saint Francis Medical Center
      • Cape Girardeau、Missouri、美国、63703
        • Mercy Cancer Center - Cape Girardeau
      • Farmington、Missouri、美国、63640
        • Parkland Health Center - Farmington
      • Jefferson City、Missouri、美国、65109
        • MU Health Care Goldschmidt Cancer Center
      • Joplin、Missouri、美国、64804
        • Freeman Health System
      • Joplin、Missouri、美国、64804
        • Mercy Hospital Joplin
      • Osage Beach、Missouri、美国、65065
        • Lake Regional Hospital
      • Rolla、Missouri、美国、65401
        • Mercy Clinic-Rolla-Cancer and Hematology
      • Rolla、Missouri、美国、65401
        • Phelps Health Delbert Day Cancer Institute
      • Saint Joseph、Missouri、美国、64506
        • Heartland Regional Medical Center
      • Sainte Genevieve、Missouri、美国、63670
        • Sainte Genevieve County Memorial Hospital
      • Springfield、Missouri、美国、65807
        • CoxHealth South Hospital
      • Springfield、Missouri、美国、65804
        • Mercy Hospital Springfield
      • St Louis、Missouri、美国、63131
        • Missouri Baptist Medical Center
      • St Louis、Missouri、美国、63141
        • Mercy Hospital Saint Louis
      • St Louis、Missouri、美国、63128
        • Mercy Hospital South
      • Sullivan、Missouri、美国、63080
        • Missouri Baptist Sullivan Hospital
      • Sunset Hills、Missouri、美国、63127
        • BJC Outpatient Center at Sunset Hills
    • Montana
      • Billings、Montana、美国、59101
        • Billings Clinic Cancer Center
      • Bozeman、Montana、美国、59715
        • Bozeman Health Deaconess Hospital
      • Butte、Montana、美国、59701
        • Saint James Community Hospital and Cancer Treatment Center
      • Great Falls、Montana、美国、59405
        • Great Falls Clinic
      • Great Falls、Montana、美国、59405
        • Benefis Sletten Cancer Institute
      • Havre、Montana、美国、59501
        • Hi-Line Sletten Cancer Center
      • Kalispell、Montana、美国、59901
        • Logan Health Medical Center
      • Missoula、Montana、美国、59802
        • Saint Patrick Hospital - Community Hospital
      • Missoula、Montana、美国、59804
        • Community Medical Center
    • Nebraska
      • Kearney、Nebraska、美国、68847
        • CHI Health Good Samaritan
      • Omaha、Nebraska、美国、68124
        • Alegent Health Bergan Mercy Medical Center
      • Omaha、Nebraska、美国、68122
        • Alegent Health Immanuel Medical Center
      • Omaha、Nebraska、美国、68130
        • Alegent Health Lakeside Hospital
      • Omaha、Nebraska、美国、68131
        • Creighton University Medical Center
    • Nevada
      • Henderson、Nevada、美国、89052
        • Comprehensive Cancer Centers of Nevada - Henderson
      • Henderson、Nevada、美国、89052
        • OptumCare Cancer Care at Seven Hills
      • Las Vegas、Nevada、美国、89144
        • Summerlin Hospital Medical Center
      • Las Vegas、Nevada、美国、89102
        • OptumCare Cancer Care at Charleston
      • Las Vegas、Nevada、美国、89106
        • Radiation Oncology Centers of Nevada Central
      • Las Vegas、Nevada、美国、89109
        • GenesisCare USA - Las Vegas
      • Las Vegas、Nevada、美国、89119
        • Radiation Oncology Centers of Nevada Southeast
      • Las Vegas、Nevada、美国、89128
        • Comprehensive Cancer Centers of Nevada - Northwest
      • Las Vegas、Nevada、美国、89128
        • OptumCare Cancer Care at MountainView
      • Las Vegas、Nevada、美国、89135
        • Alliance for Childhood Diseases/Cure 4 the Kids Foundation
      • Las Vegas、Nevada、美国、89144
        • Comprehensive Cancer Centers of Nevada - Town Center
      • Las Vegas、Nevada、美国、89144
        • Comprehensive Cancer Centers of Nevada-Summerlin
      • Las Vegas、Nevada、美国、89148
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas、Nevada、美国、89148
        • OptumCare Cancer Care at Fort Apache
      • Las Vegas、Nevada、美国、89169
        • Comprehensive Cancer Centers of Nevada - Central Valley
      • Las Vegas、Nevada、美国、89148
        • GenesisCare USA - Fort Apache
      • Reno、Nevada、美国、89502
        • Renown Regional Medical Center
      • Reno、Nevada、美国、89503
        • Saint Mary's Regional Medical Center
      • Reno、Nevada、美国、89509
        • Radiation Oncology Associates
    • New Hampshire
      • Concord、New Hampshire、美国、03301
        • New Hampshire Oncology Hematology PA-Concord
      • Lebanon、New Hampshire、美国、03756
        • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
      • Londonderry、New Hampshire、美国、03053
        • The Dana-Farber Cancer Institute at Londonderry
      • Manchester、New Hampshire、美国、03103
        • Solinsky Center for Cancer Care
    • New Jersey
      • Basking Ridge、New Jersey、美国、07920
        • Memorial Sloan Kettering Basking Ridge
      • Camden、New Jersey、美国、08103
        • Cooper Hospital University Medical Center
      • Cherry Hill、New Jersey、美国、08002
        • Jefferson Cherry Hill Hospital
      • Middletown、New Jersey、美国、07748
        • Memorial Sloan Kettering Monmouth
      • Montvale、New Jersey、美国、07645
        • Memorial Sloan Kettering Bergen
      • Morristown、New Jersey、美国、07960
        • Morristown Medical Center
      • Paramus、New Jersey、美国、07652
        • The Valley Hospital - Luckow Pavilion
      • Pompton、New Jersey、美国、07444
        • Chilton Medical Center
      • Ridgewood、New Jersey、美国、07450
        • Valley Health System Ridgewood Campus
      • Sewell、New Jersey、美国、08080
        • Sidney Kimmel Cancer Center Washington Township
      • Summit、New Jersey、美国、07902
        • Overlook Hospital
      • Teaneck、New Jersey、美国、07666
        • Holy Name Hospital
      • Westwood、New Jersey、美国、07675
        • Valley Health System-Hematology/Oncology
    • New Mexico
      • Albuquerque、New Mexico、美国、87106
        • University of New Mexico Cancer Center
    • New York
      • Brooklyn、New York、美国、11215
        • New York-Presbyterian/Brooklyn Methodist Hospital
      • Brooklyn、New York、美国、11220
        • NYU Langone Hospital - Brooklyn
      • Buffalo、New York、美国、14263
        • Roswell Park Cancer Institute
      • Commack、New York、美国、11725
        • Memorial Sloan Kettering Commack
      • Flushing、New York、美国、11355
        • The New York Hospital Medical Center of Queens
      • Forest Hills、New York、美国、11375
        • Northwell Health Physicians Partners Radiation Medicine at Queens
      • Glens Falls、New York、美国、12801
        • Glens Falls Hospital
      • Greenlawn、New York、美国、11740
        • Northwell Health Cancer Institute at Huntington
      • Harrison、New York、美国、10604
        • Memorial Sloan Kettering Westchester
      • Lake Success、New York、美国、11042
        • Northwell Health/Center for Advanced Medicine
      • Manhasset、New York、美国、11030
        • North Shore University Hospital
      • Middletown、New York、美国、10940
        • Garnet Health Medical Center
      • Mineola、New York、美国、11501
        • NYU Langone Hospital - Long Island
      • Mount Kisco、New York、美国、10549
        • Northern Westchester Hospital
      • New Hyde Park、New York、美国、11040
        • Long Island Jewish Medical Center
      • New York、New York、美国、10065
        • Memorial Sloan Kettering Cancer Center
      • New York、New York、美国、10019
        • Mount Sinai West
      • New York、New York、美国、10029
        • Mount Sinai Hospital
      • New York、New York、美国、10032
        • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
      • New York、New York、美国、10065
        • NYP/Weill Cornell Medical Center
      • New York、New York、美国、10016
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone
      • New York、New York、美国、10075
        • Lenox Hill Hospital
      • New York、New York、美国、10065
        • Manhattan Eye Ear and Throat Hospital
      • Oswego、New York、美国、13126
        • Upstate Cancer Center at Oswego
      • Rego Park、New York、美国、11374
        • Queens Cancer Center
      • Rochester、New York、美国、14642
        • University of Rochester
      • Sleepy Hollow、New York、美国、10591
        • Phelps Memorial Hospital Center
      • Syracuse、New York、美国、13210
        • State University of New York Upstate Medical University
      • Syracuse、New York、美国、13215
        • SUNY Upstate Medical Center-Community Campus
      • The Bronx、New York、美国、10461
        • Montefiore Medical Center-Einstein Campus
      • The Bronx、New York、美国、10467
        • Montefiore Medical Center - Moses Campus
      • The Bronx、New York、美国、10461
        • Montefiore Medical Center-Weiler Hospital
      • Uniondale、New York、美国、11553
        • Memorial Sloan Kettering Nassau
      • Verona、New York、美国、13478
        • Upstate Cancer Center at Verona
      • Webster、New York、美国、14580
        • Wilmot Cancer Institute at Webster
    • North Carolina
      • Albemarle、North Carolina、美国、28002
        • Atrium Health Stanly/LCI-Albemarle
      • Cary、North Carolina、美国、27518
        • Duke Cancer Center Cary
      • Chapel Hill、North Carolina、美国、27599
        • UNC Lineberger Comprehensive Cancer Center
      • Charlotte、North Carolina、美国、28203
        • Carolinas Medical Center/Levine Cancer Institute
      • Charlotte、North Carolina、美国、28210
        • Atrium Health Pineville/LCI-Pineville
      • Charlotte、North Carolina、美国、28262
        • Atrium Health University City/LCI-University
      • Charlotte、North Carolina、美国、28211
        • Levine Cancer Institute-SouthPark
      • Charlotte、North Carolina、美国、28277
        • Levine Cancer Institute-Ballantyne
      • Clemmons、North Carolina、美国、27012
        • Wake Forest University at Clemmons
      • Concord、North Carolina、美国、28025
        • Atrium Health Cabarrus/LCI-Concord
      • Durham、North Carolina、美国、27710
        • Duke University Medical Center
      • Forest City、North Carolina、美国、28043
        • Levine Cancer Institute - Rutherford
      • Gastonia、North Carolina、美国、28054
        • Levine Cancer Institute-Gaston
      • Greenville、North Carolina、美国、27834
        • East Carolina University
      • High Point、North Carolina、美国、27262
        • Hayworth Cancer Center
      • Hillsborough、North Carolina、美国、27278
        • University of North Carolina-Hillsborough Campus
      • Lincolnton、North Carolina、美国、28092
        • Atrium Health Lincoln/LCI-Lincolnton
      • Matthews、North Carolina、美国、28104
        • Levine Cancer Institute - Union West
      • Monroe、North Carolina、美国、28112
        • Atrium Health Union/LCI-Union
      • Raleigh、North Carolina、美国、27609
        • Duke Cancer Center Raleigh
      • Shelby、North Carolina、美国、28150
        • Atrium Health Cleveland/LCI-Cleveland
      • Wilkesboro、North Carolina、美国、28659
        • Wake Forest Baptist Health - Wilkes Medical Center
      • Winston-Salem、North Carolina、美国、27157
        • Wake Forest University Health Sciences
    • North Dakota
      • Bismarck、North Dakota、美国、58501
        • Sanford Bismarck Medical Center
      • Fargo、North Dakota、美国、58122
        • Sanford Roger Maris Cancer Center
      • Fargo、North Dakota、美国、58103
        • Essentia Health Cancer Center-South University Clinic
      • Fargo、North Dakota、美国、58122
        • Sanford Broadway Medical Center
      • Jamestown、North Dakota、美国、58401
        • Essentia Health - Jamestown Clinic
    • Ohio
      • Beavercreek、Ohio、美国、45431
        • Indu and Raj Soin Medical Center
      • Boardman、Ohio、美国、44512
        • Saint Elizabeth Boardman Hospital
      • Canton、Ohio、美国、44710
        • Aultman Health Foundation
      • Centerville、Ohio、美国、45459
        • Dayton Physicians LLC-Miami Valley South
      • Cincinnati、Ohio、美国、45220
        • Good Samaritan Hospital - Cincinnati
      • Cincinnati、Ohio、美国、45242
        • Bethesda North Hospital
      • Cincinnati、Ohio、美国、45236
        • Oncology Hematology Care Inc-Kenwood
      • Cleveland、Ohio、美国、44109
        • MetroHealth Medical Center
      • Columbus、Ohio、美国、43210
        • Ohio State University Comprehensive Cancer Center
      • Dayton、Ohio、美国、45415
        • Dayton Physician LLC - Englewood
      • Findlay、Ohio、美国、45840
        • Blanchard Valley Hospital
      • Findlay、Ohio、美国、45840
        • Armes Family Cancer Center
      • Findlay、Ohio、美国、45840
        • Orion Cancer Care
      • Franklin、Ohio、美国、45005
        • Dayton Physicians LLC-Atrium
      • Greenville、Ohio、美国、45331
        • Wayne Hospital
      • Greenville、Ohio、美国、45331
        • Dayton Physicians LLC-Wayne
      • Kettering、Ohio、美国、45429
        • Kettering Medical Center
      • Kettering、Ohio、美国、45409
        • Greater Dayton Cancer Center
      • Troy、Ohio、美国、45373
        • Dayton Physicians LLC - Troy
      • Warren、Ohio、美国、44484
        • Saint Joseph Warren Hospital
      • Youngstown、Ohio、美国、44501
        • Saint Elizabeth Youngstown Hospital
    • Oklahoma
      • Oklahoma City、Oklahoma、美国、73104
        • University of Oklahoma Health Sciences Center
      • Oklahoma City、Oklahoma、美国、73120
        • Mercy Hospital Oklahoma City
    • Oregon
      • Bend、Oregon、美国、97701
        • Saint Charles Health System
      • Clackamas、Oregon、美国、97015
        • Clackamas Radiation Oncology Center
      • Clackamas、Oregon、美国、97015
        • Providence Cancer Institute Clackamas Clinic
      • Coos Bay、Oregon、美国、97420
        • Bay Area Hospital
      • Gresham、Oregon、美国、97030
        • Legacy Mount Hood Medical Center
      • Newberg、Oregon、美国、97132
        • Providence Newberg Medical Center
      • Oregon City、Oregon、美国、97045
        • Providence Willamette Falls Medical Center
      • Portland、Oregon、美国、97210
        • Legacy Good Samaritan Hospital and Medical Center
      • Portland、Oregon、美国、97213
        • Providence Portland Medical Center
      • Portland、Oregon、美国、97225
        • Providence Saint Vincent Medical Center
      • Tualatin、Oregon、美国、97062
        • Legacy Meridian Park Hospital
    • Pennsylvania
      • Allentown、Pennsylvania、美国、18103
        • Lehigh Valley Hospital-Cedar Crest
      • Altoona、Pennsylvania、美国、16601
        • UPMC Altoona
      • Beaver、Pennsylvania、美国、15009
        • UPMC-Heritage Valley Health System Beaver
      • Bethlehem、Pennsylvania、美国、18017
        • Lehigh Valley Hospital - Muhlenberg
      • Camp Hill、Pennsylvania、美国、17011
        • UPMC Camp Hill
      • Carlisle、Pennsylvania、美国、17015
        • Carlisle Regional Cancer Center
      • Chadds Ford、Pennsylvania、美国、19317
        • Christiana Care Health System-Concord Health Center
      • East Stroudsburg、Pennsylvania、美国、18301
        • Pocono Medical Center
      • Erie、Pennsylvania、美国、16505
        • UPMC Hillman Cancer Center Erie
      • Erie、Pennsylvania、美国、16544
        • Saint Vincent Hospital
      • Farrell、Pennsylvania、美国、16121
        • UPMC Cancer Center at UPMC Horizon
      • Greensburg、Pennsylvania、美国、15601
        • UPMC Cancer Centers - Arnold Palmer Pavilion
      • Greenville、Pennsylvania、美国、16125
        • UPMC Hillman Cancer Center in Greenville/UPMC Horizon
      • Harrisburg、Pennsylvania、美国、17109
        • UPMC Pinnacle Cancer Center/Community Osteopathic Campus
      • Hershey、Pennsylvania、美国、17033-0850
        • Penn State Milton S Hershey Medical Center
      • Indiana、Pennsylvania、美国、15701
        • IRMC Cancer Center
      • Jefferson Hills、Pennsylvania、美国、15025
        • Jefferson Hospital
      • Johnstown、Pennsylvania、美国、15901
        • UPMC-Johnstown/John P. Murtha Regional Cancer Center
      • McKeesport、Pennsylvania、美国、15132
        • UPMC Cancer Center at UPMC McKeesport
      • Mechanicsburg、Pennsylvania、美国、17050
        • UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
      • Monroeville、Pennsylvania、美国、15146
        • Forbes Hospital
      • Monroeville、Pennsylvania、美国、15146
        • UPMC Hillman Cancer Center - Monroeville
      • Monroeville、Pennsylvania、美国、15146
        • UPMC Cancer Center - Monroeville
      • Moon Township、Pennsylvania、美国、15108
        • UPMC Hillman Cancer Center in Coraopolis
      • Mount Pleasant、Pennsylvania、美国、15666
        • UPMC Hillman Cancer Center - Part of Frick Hospital
      • N. Huntingdon、Pennsylvania、美国、15642
        • Arnold Palmer Cancer Center Medical Oncology Norwin
      • Natrona Heights、Pennsylvania、美国、15065
        • UPMC Cancer Center-Natrona Heights
      • New Castle、Pennsylvania、美国、16105
        • UPMC Hillman Cancer Center - New Castle
      • Philadelphia、Pennsylvania、美国、19107
        • Thomas Jefferson University Hospital
      • Philadelphia、Pennsylvania、美国、19114
        • Jefferson Torresdale Hospital
      • Pittsburgh、Pennsylvania、美国、15212
        • Allegheny General Hospital
      • Pittsburgh、Pennsylvania、美国、15224
        • West Penn Hospital
      • Pittsburgh、Pennsylvania、美国、15213
        • UPMC-Magee Womens Hospital
      • Pittsburgh、Pennsylvania、美国、15232
        • University of Pittsburgh Cancer Institute (UPCI)
      • Pittsburgh、Pennsylvania、美国、15232
        • UPMC-Shadyside Hospital
      • Pittsburgh、Pennsylvania、美国、15215
        • UPMC-Saint Margaret
      • Pittsburgh、Pennsylvania、美国、15237
        • UPMC-Passavant Hospital
      • Pittsburgh、Pennsylvania、美国、15243
        • UPMC-Saint Clair Hospital Cancer Center
      • Pittsburgh、Pennsylvania、美国、15219
        • UPMC-Mercy Hospital
      • Seneca、Pennsylvania、美国、16346
        • UPMC Cancer Center at UPMC Northwest
      • Uniontown、Pennsylvania、美国、15401
        • UPMC Uniontown Hospital Radiation Oncology
      • Uniontown、Pennsylvania、美国、15401
        • UPMC Cancer Center-Uniontown
      • Washington、Pennsylvania、美国、15301
        • UPMC Washington Hospital Radiation Oncology
      • Washington、Pennsylvania、美国、15301
        • UPMC Cancer Center-Washington
      • West Chester、Pennsylvania、美国、19380
        • Chester County Hospital
      • West Reading、Pennsylvania、美国、19611
        • Reading Hospital
      • Wexford、Pennsylvania、美国、15090
        • Wexford Health and Wellness Pavilion
      • Williamsport、Pennsylvania、美国、17754
        • Divine Providence Hospital
      • Willow Grove、Pennsylvania、美国、19090
        • Asplundh Cancer Pavilion
      • York、Pennsylvania、美国、17408
        • UPMC Memorial
    • South Carolina
      • Anderson、South Carolina、美国、29621
        • AnMed Health Cancer Center
      • Charleston、South Carolina、美国、29425
        • Medical University of South Carolina
      • Gaffney、South Carolina、美国、29341
        • Gibbs Cancer Center-Gaffney
      • Georgetown、South Carolina、美国、29440
        • Tidelands Georgetown Memorial Hospital
      • Greenville、South Carolina、美国、29605
        • Prisma Health Cancer Institute - Faris
      • Greenville、South Carolina、美国、29615
        • Prisma Health Cancer Institute - Eastside
      • Greer、South Carolina、美国、29650
        • Prisma Health Cancer Institute - Greer
      • Greer、South Carolina、美国、29651
        • Gibbs Cancer Center-Pelham
      • Murrells Inlet、South Carolina、美国、29576
        • MUSC Health Tidelands Health Radiation Therapy Center
      • Rock Hill、South Carolina、美国、29732
        • Levine Cancer Institute-Rock Hill
      • Rock Hill、South Carolina、美国、29730
        • Rock Hill Radiation Therapy Center
      • Seneca、South Carolina、美国、29672
        • Prisma Health Cancer Institute - Seneca
      • Spartanburg、South Carolina、美国、29303
        • Spartanburg Medical Center
      • Union、South Carolina、美国、29379
        • SMC Center for Hematology Oncology Union
      • West Columbia、South Carolina、美国、29169
        • Lexington Medical Center
    • South Dakota
      • Aberdeen、South Dakota、美国、57401
        • Avera Cancer Institute-Aberdeen
      • Mitchell、South Dakota、美国、57301
        • Avera Cancer Institute - Mitchell
      • Pierre、South Dakota、美国、57501
        • Avera Cancer Institute at Pierre
      • Sioux Falls、South Dakota、美国、57105
        • Avera Cancer Institute
      • Sioux Falls、South Dakota、美国、57117-5134
        • Sanford USD Medical Center - Sioux Falls
      • Sioux Falls、South Dakota、美国、57104
        • Sanford Cancer Center Oncology Clinic
      • Yankton、South Dakota、美国、57078
        • Avera Cancer Institute at Yankton
    • Tennessee
      • Collierville、Tennessee、美国、38017
        • Baptist Memorial Hospital and Cancer Center-Collierville
      • Germantown、Tennessee、美国、38138
        • The West Clinic - Wolf River
      • Memphis、Tennessee、美国、38120
        • Baptist Memorial Hospital and Cancer Center-Memphis
      • Nashville、Tennessee、美国、37232
        • Vanderbilt University/Ingram Cancer Center
      • Nashville、Tennessee、美国、37204
        • Vanderbilt Breast Center at One Hundred Oaks
    • Texas
      • Amarillo、Texas、美国、79106
        • The Don and Sybil Harrington Cancer Center
      • Conroe、Texas、美国、77384
        • MD Anderson in The Woodlands
      • Dallas、Texas、美国、75235
        • Parkland Memorial Hospital
      • Dallas、Texas、美国、75390
        • UT Southwestern/Simmons Cancer Center-Dallas
      • Dallas、Texas、美国、75237
        • UT Southwestern Simmons Cancer Center - RedBird
      • Fort Worth、Texas、美国、76104
        • UT Southwestern/Simmons Cancer Center-Fort Worth
      • Fort Worth、Texas、美国、76104
        • Tarrant County Hospital District/JPS Health Network
      • Houston、Texas、美国、77030
        • M D Anderson Cancer Center
      • Houston、Texas、美国、77026-1967
        • Lyndon Baines Johnson General Hospital
      • Houston、Texas、美国、77030
        • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
      • Houston、Texas、美国、77030
        • Ben Taub General Hospital
      • Houston、Texas、美国、77079
        • MD Anderson West Houston
      • League City、Texas、美国、77573
        • MD Anderson League City
      • Richardson、Texas、美国、75080
        • UT Southwestern Clinical Center at Richardson/Plano
      • Round Rock、Texas、美国、78665
        • Scott and White Healthcare Round Rock
      • San Antonio、Texas、美国、78229
        • University of Texas Health Science Center at San Antonio
      • Sugar Land、Texas、美国、77478
        • MD Anderson in Sugar Land
      • Temple、Texas、美国、76508
        • Scott and White Memorial Hospital
    • Utah
      • Farmington、Utah、美国、84025
        • Farmington Health Center
      • Salt Lake City、Utah、美国、84112
        • Huntsman Cancer Institute/University of Utah
      • Salt Lake City、Utah、美国、84106
        • University of Utah Sugarhouse Health Center
    • Vermont
      • Berlin Corners、Vermont、美国、05602
        • Central Vermont Medical Center/National Life Cancer Treatment
      • Burlington、Vermont、美国、05401
        • University of Vermont Medical Center
      • Burlington、Vermont、美国、05405
        • University of Vermont and State Agricultural College
    • Virginia
      • Charlottesville、Virginia、美国、22908
        • University of Virginia Cancer Center
      • Fairfax、Virginia、美国、22031
        • Inova Schar Cancer Institute
      • Fairfax、Virginia、美国、22033
        • Inova Fair Oaks Hospital
      • Falls Church、Virginia、美国、22042
        • Inova Fairfax Hospital
      • Leesburg、Virginia、美国、20176
        • Inova Loudoun Hospital
      • Martinsville、Virginia、美国、24112
        • Sovah Health Martinsville
      • Richmond、Virginia、美国、23235
        • VCU Massey Cancer Center at Stony Point
      • Richmond、Virginia、美国、23229
        • Virginia Cancer Institute
      • Richmond、Virginia、美国、23298
        • VCU Massey Comprehensive Cancer Center
    • Washington
      • Aberdeen、Washington、美国、98520
        • Providence Regional Cancer System-Aberdeen
      • Bellingham、Washington、美国、98225
        • PeaceHealth Saint Joseph Medical Center
      • Centralia、Washington、美国、98531
        • Providence Regional Cancer System-Centralia
      • Edmonds、Washington、美国、98026
        • Swedish Cancer Institute-Edmonds
      • Everett、Washington、美国、98201
        • Providence Regional Cancer Partnership
      • Issaquah、Washington、美国、98029
        • Swedish Cancer Institute-Issaquah
      • Kennewick、Washington、美国、99336
        • Kadlec Clinic Hematology and Oncology
      • Kirkland、Washington、美国、98034
        • FHCC at EvergreenHealth
      • Lacey、Washington、美国、98503
        • Providence Regional Cancer System-Lacey
      • Longview、Washington、美国、98632
        • PeaceHealth Saint John Medical Center
      • Mount Vernon、Washington、美国、98274
        • Skagit Regional Health Cancer Care Center
      • Renton、Washington、美国、98055
        • Valley Medical Center
      • Seattle、Washington、美国、98101
        • Virginia Mason Medical Center
      • Seattle、Washington、美国、98107
        • Swedish Medical Center-Ballard Campus
      • Seattle、Washington、美国、98122
        • Swedish Medical Center-First Hill
      • Seattle、Washington、美国、98195
        • University of Washington Medical Center - Montlake
      • Seattle、Washington、美国、98109
        • Fred Hutchinson Cancer Center
      • Sedro-Woolley、Washington、美国、98284
        • PeaceHealth United General Medical Center
      • Silverdale、Washington、美国、98383
        • Saint Michael Cancer Center
      • Vancouver、Washington、美国、98686
        • Legacy Salmon Creek Hospital
      • Vancouver、Washington、美国、98664
        • PeaceHealth Southwest Medical Center
      • Vancouver、Washington、美国、98684
        • Legacy Cancer Institute Medical Oncology and Day Treatment
      • Walla Walla、Washington、美国、99362
        • Providence Saint Mary Regional Cancer Center
      • Yakima、Washington、美国、98902
        • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
    • West Virginia
      • Bridgeport、West Virginia、美国、26330
        • United Hospital Center
      • Morgantown、West Virginia、美国、26506
        • West Virginia University Healthcare
      • Parkersburg、West Virginia、美国、26101
        • Camden Clark Medical Center
    • Wisconsin
      • Antigo、Wisconsin、美国、54409
        • Langlade Hospital and Cancer Center
      • Ashland、Wisconsin、美国、54806
        • Duluth Clinic Ashland
      • Ashland、Wisconsin、美国、54806
        • Northwest Wisconsin Cancer Center
      • Burlington、Wisconsin、美国、53105
        • Aurora Cancer Care-Southern Lakes VLCC
      • Eau Claire、Wisconsin、美国、54701
        • Marshfield Medical Center-EC Cancer Center
      • Germantown、Wisconsin、美国、53022
        • Aurora Health Care Germantown Health Center
      • Grafton、Wisconsin、美国、53024
        • Aurora Cancer Care-Grafton
      • Green Bay、Wisconsin、美国、54311
        • Aurora BayCare Medical Center
      • Green Bay、Wisconsin、美国、54301
        • Saint Vincent Hospital Cancer Center Green Bay
      • Green Bay、Wisconsin、美国、54303
        • Saint Vincent Hospital Cancer Center at Saint Mary's
      • Hayward、Wisconsin、美国、54843
        • Essentia Health-Hayward Clinic
      • Kenosha、Wisconsin、美国、53142
        • Aurora Cancer Care-Kenosha South
      • Marinette、Wisconsin、美国、54143
        • Aurora Bay Area Medical Group-Marinette
      • Marshfield、Wisconsin、美国、54449
        • Marshfield Medical Center-Marshfield
      • Medford、Wisconsin、美国、54451
        • Aspirus Medford Hospital
      • Menomonee Falls、Wisconsin、美国、53051
        • Froedtert Menomonee Falls Hospital
      • Milwaukee、Wisconsin、美国、53226
        • Medical College of Wisconsin
      • Milwaukee、Wisconsin、美国、53209
        • Aurora Cancer Care-Milwaukee
      • Milwaukee、Wisconsin、美国、53215
        • Aurora Saint Luke's Medical Center
      • Milwaukee、Wisconsin、美国、53233
        • Aurora Sinai Medical Center
      • Minocqua、Wisconsin、美国、54548
        • Marshfield Medical Center - Minocqua
      • Mukwonago、Wisconsin、美国、53149
        • ProHealth D N Greenwald Center
      • New Richmond、Wisconsin、美国、54017
        • Cancer Center of Western Wisconsin
      • Oak Creek、Wisconsin、美国、53154
        • Drexel Town Square Health Center
      • Oconomowoc、Wisconsin、美国、53066
        • ProHealth Oconomowoc Memorial Hospital
      • Oshkosh、Wisconsin、美国、54904
        • Vince Lombardi Cancer Clinic - Oshkosh
      • Racine、Wisconsin、美国、53406
        • Aurora Cancer Care-Racine
      • Rhinelander、Wisconsin、美国、54501
        • Aspirus Cancer Care - James Beck Cancer Center
      • Rice Lake、Wisconsin、美国、54868
        • Marshfield Medical Center-Rice Lake
      • Sheboygan、Wisconsin、美国、53081
        • Vince Lombardi Cancer Clinic-Sheboygan
      • Sheboygan、Wisconsin、美国、53081
        • Saint Vincent Hospital Cancer Center at Sheboygan
      • Spooner、Wisconsin、美国、54801
        • Essentia Health-Spooner Clinic
      • Stevens Point、Wisconsin、美国、54482
        • Marshfield Medical Center-River Region at Stevens Point
      • Stevens Point、Wisconsin、美国、54481
        • Aspirus Cancer Care - Stevens Point
      • Sturgeon Bay、Wisconsin、美国、54235-1495
        • Saint Vincent Hospital Cancer Center at Sturgeon Bay
      • Summit、Wisconsin、美国、53066
        • Aurora Medical Center in Summit
      • Superior、Wisconsin、美国、54880
        • Essentia Health Saint Mary's Hospital - Superior
      • Two Rivers、Wisconsin、美国、54241
        • Vince Lombardi Cancer Clinic-Two Rivers
      • Waukesha、Wisconsin、美国、53188
        • UW Cancer Center at ProHealth Care
      • Wausau、Wisconsin、美国、54401
        • Aspirus Regional Cancer Center
      • Wauwatosa、Wisconsin、美国、53226
        • Aurora Cancer Care-Milwaukee West
      • West Allis、Wisconsin、美国、53227
        • Aurora West Allis Medical Center
      • West Bend、Wisconsin、美国、53095
        • Froedtert West Bend Hospital/Kraemer Cancer Center
      • Weston、Wisconsin、美国、54476
        • Marshfield Medical Center - Weston
      • Wisconsin Rapids、Wisconsin、美国、54494
        • Aspirus Cancer Care - Wisconsin Rapids
    • Wyoming
      • Sheridan、Wyoming、美国、82801
        • Welch Cancer Center

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Histologic Documentation: rectal adenocarcinoma, mismatch repair proficient (pMMR)

  • Stage: Clinical stage II or III rectal adenocarcinoma defined as T4N0 or any T with node positive disease (any T, N+); also T3N0 requiring abdominal perineal resection (APR) or coloanal anastomosis

  • Tumor site: Rectum; distal edge of the tumor =< 12cm from the anal verge (as determined by surgeon's endoscopic assessment; MRI can be used to compliment this information, but endoscopy should be the primary means of assessment)

  • No prior systemic chemotherapy, targeted therapy, or immunotherapy; or radiation therapy administered as treatment for colorectal cancer within the past 5 years is allowed. No local approaches to excising the rectal cancer (even if done for diagnostic purposes) are allowed (e.g., transanal excision [open or minimally invasive], local excision, endoscopic submucosal dissection or endoscopic submucosal resection).

  • Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects

    * Therefore, for women of childbearing potential only, a negative pregnancy test (urine or serum according to institutional guidelines) done =< 14 days prior to registration is required. Female subjects agree to use highly effective contraception combined with an additional barrier method (e.g, diaphragm, with a spermicide) while on study and for >= 9 months after last dose of study drug, and the same criteria are applicable to male subjects if they have a partner of childbirth potential. Male subject agrees to use a condom and not donate sperm while in this study and for >= 6 months after the last treatment

  • Age >= 18 years

  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (or Karnofsky >= 60%)

  • Absolute neutrophil count (ANC) >= 1,500/mm^3

  • Platelet count >= 100,000/mm

  • Creatinine =< 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance >= 50 mL/min

    ^3

  • Total bilirubin =< 1.5 x upper limit of normal (ULN)

  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 x upper limit of normal (ULN)

  • No upper rectal tumors (i.e., distal portion of tumor must be => 12 cm from the anal verge)

  • No recurrent rectal cancer; prior transanal excision, prior distal sigmoid cancer with a low anastomosis or prior endoscopic submucosal dissection

  • No known mismatch repair deficient rectal adenocarcinoma

  • HIV-infected patients on effective anti-retro viral therapy with undetectable viral load within 6 months are eligible for this trial

  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardio toxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification1. To be eligible for this trial, patients should be class 2B or better

  • Testing for dihydropyrimidine dehydrogenase (DPD) deficiency is not required. However, when available, patients with complete lack of DPD should not be treated with fluoropyrimidines (such patients must not be enrolled or if initiated on therapy and noted to have fluoropyrimidine related toxicities be taken off protocol; dose reductions for patients with partial deficiency may be done per local guidelines

  • Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study

    • Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment
    • Once systemic chemotherapy has been completed and the patient is either in surveillance or being considered for surgery then medically necessary CYP3A4 medications can be resume

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：顺序分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：Arm I (LCRT, FOLFOX or CAPOX)

LCRT: Patients undergo long-course chemoradiation therapy for up to 5 weeks. Consolidation: Patients receive either: FOLFOX (consisting of leucovorin IV over 2 hours on day 1 of each cycle, fluorouracil IV bolus over 2-4 minutes and IV continuous infusion over 46-48 hours on day 1 of each cycle, and oxaliplatin IV over 2 hours on day 1 of each cycle) or CAPOX (consisting of capecitabine PO on days 1-14 of each cycle, and oxaliplatin IV over 2 hours on day 1 of each cycle). Treatment with FOLFOX repeats every 2 weeks for up to 8 cycles (16 weeks) in the absence of disease progression or unacceptable toxicity. Treatment with CAPOX repeats every 3 weeks for up to 5 cycles (15 weeks) in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, collection of blood samples and sigmoidoscopy throughout the trial and undergo biopsy during screening.
药品：Capecitabine

Given PO

药品：Oxaliplatin

Given IV

药品：5-fluorouracil

Given IV

药品：Leucovorin calcium

Given IV

辐射：Long Course Chemoradiotherapy

Receive LCRT

程序：Computed Tomography

undergo CT

程序：Magnetic Resonance Imaging

undergo MRI

程序：Sigmoidoscopy

undergo sigmoidoscopy

程序：biopsy

undergo biopsy
实验性的：Arm II (LCRT, FOLFIRINOX)

LCRT: Patients undergo long-course chemoradiation therapy for up to 5 weeks. CONSOLIDATION: Patients receive FOLFIRINOX (consisting of leucovorin over 2 hours on day 1 of each cycle, fluorouracil IV continuous infusion over 46-48 hours on day 1 of each cycle, oxaliplatin IV over 2 hours on day 1 of each cycle, and irinotecan IV over 30-90 minutes on day 1 of each cycle). Treatment with FOLFIRINOX repeats every 2 weeks for up to 8 cycles (16 weeks) in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI and collection of blood samples and sigmoidoscopy throughout the trial and undergo biopsy during screening.
药品：Capecitabine

Given PO

药品：Oxaliplatin

Given IV

药品：5-fluorouracil

Given IV

药品：Leucovorin calcium

Given IV

辐射：Long Course Chemoradiotherapy

Receive LCRT

程序：Computed Tomography

undergo CT

程序：Magnetic Resonance Imaging

undergo MRI

程序：Sigmoidoscopy

undergo sigmoidoscopy

程序：biopsy

undergo biopsy

药品：Irinotecan

Given IV

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Clincal Complete Response (cCR) Rates (Phase II)
大体时间：Up to 5 years

Defined as the number of patients who achieved cCR at the end of total neoadjuvant therapy (TNT) divided by number of patients included in the analysis population. This endpoint will be assessed within 8-12 weeks after completion of TNT. If there is a cCR, then the patient will be counted in the numerator. If there is a near-complete response (nCR) then a re-evaluation within 4-8 weeks will be performed. If an nCR evolved to a cCR, then the patient will be counted in the numerator. Otherwise, the patient will be deemed as NOT achieving cCR status. Difference of proportions test will be conducted to compare cCR rate in the experimental arm to cCR rate in the control arm. If the one-sided p-value of the comparison is < 0.05 (difference in proportion > 9.3%), then we will conclude the cCR rate in the experimental arm is superior to the control arm.
Up to 5 years
Disease-free survival (DFS) rate (Phase III)
大体时间：From date of randomization, assessed up to 5 years

Defined as the time from date of randomization to the date of first occurrence of the following events: death due to all causes, tumor that recurs locally after an R0 total mesorectal excision (TME), tumor that regrows after an initial apparent clinical and radiological CR and cannot be surgically removed with an R0 TME, and M1 disease diagnosed at any point after the initiation of treatment. Will be estimated, in each arm, using the method of Kaplan-Meier and compared by a stratified Cox regression model.
From date of randomization, assessed up to 5 years

次要结果测量

结果测量
措施说明
大体时间
Organ-preservation time (OPT)
大体时间：From date of randomization, assessed up to 5 years

Defined as time from the date of randomization to the date of the first occurrence of the following events: TME performed or attempted, tumor that regrows after an initial apparent clinical and radiological complete response (CR) and death due to all causes. Will be estimated, in each arm, using the method of Kaplan-Meier and treatment compared by a stratified Cox regression model.
From date of randomization, assessed up to 5 years
Time to distant metastasis (TDM)
大体时间：From the date of randomization to the date of first documented distant metastasis, assessed up to 5 years

Will be estimated, in each arm, using the method of Kaplan-Meier and compared by a stratified Cox regression model.
From the date of randomization to the date of first documented distant metastasis, assessed up to 5 years
Overall survival (OS)
大体时间：From the date of randomization to the date of death due to all causes, assessed up to 5 years

Will be estimated, in each arm, using the method of Kaplan-Meier and compared by a stratified Cox regression model.
From the date of randomization to the date of death due to all causes, assessed up to 5 years
Incidence of adverse events (AEs)
大体时间：Up to 5 years

Defined as the proportion of patients experienced at least one Grade 3, Grade 4, or Grade 5 of each type of AE. The overall adverse event rates for grade 3 or higher adverse events will be compared between two treatment groups using Chi-square test (or Fisher's exact test if the data in the contingency table is sparse).
Up to 5 years
Sustained cCR
大体时间：Up to 5 years

Defined as a binary endpoint with two statuses: responder and non-responder. Responders are defined as those evaluable patients who achieved at least one of the following within 3 years after randomization:

  • Had TME and the pathologic outcome is pathologic complete response
  • Had a cCR, were on watch and wait (WW) with no regrowth and no distant metastases
  • Had nCR, were on WW with no regrowth and no distant metastases Non-responders are defined as all patients who did not meet the criteria as noted above for the responders.
Up to 5 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Alliance for Clinical Trials in Oncology

合作者

National Cancer Institute (NCI)

调查人员

  • 学习椅：J. Joshua Smith, MD、Memorial Sloan Kettering Cancer Center

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2022年12月8日

初级完成 (估计的)

2030年7月1日

研究完成 (估计的)

2037年7月1日

研究注册日期

首次提交

2022年11月1日

首先提交符合 QC 标准的

2022年11月2日

首次发布 (实际的)

2022年11月9日

研究记录更新

最后更新发布 (实际的)

2026年9月25日

上次提交的符合 QC 标准的更新

2026年9月23日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • A022104
  • U10CA180821 (美国 NIH 拨款/合同)
  • NCI-2022-07800 (其他标识符：NCI)
  • NRG-GI010 (其他标识符：NRG Oncology)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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