Gemcitabine Hydrochloride or Pemetrexed Disodium and Carboplatin With or Without Celecoxib in Treating Patients With Advanced Non-Small Cell Lung Cancer
2018년 6월 26일 업데이트: Alliance for Clinical Trials in Oncology
A Randomized Phase III Double Blind Trial Evaluating Selective COX-2 Inhibition in COX-2 Expressing Advanced Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium and celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving gemcitabine hydrochloride or pemetrexed disodium together with carboplatin is more effective with or without celecoxib in treating non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying gemcitabine hydrochloride, pemetrexed disodium, and carboplatin to compare how well they work when given together with celecoxib or a placebo in treating patients with advanced non-small cell lung cancer.
연구 개요
상세 설명
OBJECTIVES:
Primary
- To confirm the beneficial effect of gemcitabine hydrochloride or pemetrexed disodium in combination with carboplatin with or without celecoxib in patients with advanced non-small cell lung cancer that expresses COX-2.
Secondary
- To describe the response rate in patients treated with these regimens.
- To describe the distribution of progression-free survival (PFS) and overall survival of patients treated with these regimens.
- To compare the PFS of patients with COX-2 index ≥ 2 (adjusting for CYP2C9 genotype and celecoxib trough concentrations as covariates) treated with these regimens.
- To correlate urinary PGE-M level with COX-2 expression, COX-2 inhibition, and outcome.
- To evaluate the association between the -765G/C polymorphism in PTGS2 and COX-2 expression in non-small cell lung cancer specimens.
- To characterize a trough plasma celecoxib concentration which will be used as a measure of patient adherence to study treatment and which may be used in future studies for correlations with genotype and pharmacodynamic outcomes.
OUTLINE: This is a multicenter study. Patients are stratified according to gender, disease stage (IIIB vs IV), histology (squamous cell carcinoma vs non-squamous cell carcinoma), smoking status (never/former light smoker [defined as ≤ 10 pack years AND quit ≥ 1 year ago] vs smoker), and COX-2 expression status (COX-2 index ≥ 4 vs COX-2 index ≥ 2 but < 4). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gemcitabine hydrochloride* IV on days 1 and 8 OR pemetrexed disodium* IV on day 1. Patients also receive carboplatin IV on day 1 and oral celecoxib twice daily on days 1-21.
- Arm II: Patients receive gemcitabine hydrochloride* OR pemetrexed disodium* and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 1-21.
- NOTE: *Patients with squamous cell carcinoma receive gemcitabine hydrochloride; patients with non-squamous cell carcinoma receive pemetrexed disodium.
In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with responding or stable disease may continue to receive celecoxib or placebo alone in the absence of disease progression or unacceptable toxicity.
Patients may undergo blood and urine sample collection periodically for correlative laboratory studies.
After completion of study therapy, patients are followed up every 2 months for 2 years and then every 6 months for 3 years.
연구 유형
중재적
등록 (실제)
313
단계
- 3단계
연락처 및 위치
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연구 장소
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Alabama
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Anniston, Alabama, 미국, 36207
- Regional Medical Center
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Arizona
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Scottsdale, Arizona, 미국, 85259-5499
- Mayo Clinic Scottsdale
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Arkansas
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Jonesboro, Arkansas, 미국, 72401
- NEA Medical Clinic - East Matthews
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Little Rock, Arkansas, 미국, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
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California
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Duarte, California, 미국, 91010-3000
- City of Hope Comprehensive Cancer Center
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La Jolla, California, 미국, 92093-0658
- Rebecca and John Moores UCSD Cancer Center
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Los Angeles, California, 미국, 90048
- Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
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Mountain View, California, 미국, 94040
- Palo Alto Medical Foundation-Camino Division
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Mountain View, California, 미국, 94040
- Camino Medical Group - Treatment Center
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Palo Alto, California, 미국, 94301
- Palo Alto Medical Foundation
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Paradise, California, 미국, 95969
- Feather River Hospital Cancer Center
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Pismo Beach, California, 미국, 93449
- PCR Oncology
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San Diego, California, 미국, 92134
- Naval Medical Center - San Diego
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San Francisco, California, 미국, 94121
- Veterans Affairs Medical Center - San Francisco
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San Francisco, California, 미국, 94115
- UCSF Helen Diller Family Comprehensive Cancer Center
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Colorado
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Fort Collins, Colorado, 미국, 80524
- Poudre Valley Hospital
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Fort Collins, Colorado, 미국, 80528
- Front Range Cancer Specialists
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Connecticut
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Hartford, Connecticut, 미국, 06105
- Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
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Middletown, Connecticut, 미국, 06457
- Middlesex Hospital Cancer Center
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Delaware
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Lewes, Delaware, 미국, 19958
- Tunnell Cancer Center at Beebe Medical Center
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Newark, Delaware, 미국, 19713
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington, District of Columbia, 미국, 20422
- Veterans Affairs Medical Center - Washington, DC
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Washington, District of Columbia, 미국, 20010
- Washington Cancer Institute at Washington Hospital Center
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Florida
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Deerfield Beach, Florida, 미국, 33064-3596
- North Broward Medical Center
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Orlando, Florida, 미국, 32803
- Florida Hospital - Orlando
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Georgia
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Columbus, Georgia, 미국, 31904
- John B. Amos Cancer Center
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Decatur, Georgia, 미국, 30033
- Veterans Affairs Medical Center - Atlanta (Decatur)
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Fort Gordon, Georgia, 미국, 30905-5650
- Dwight David Eisenhower Army Medical Center
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Gainesville, Georgia, 미국, 30501
- Northeast Georgia Medical Center
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Savannah, Georgia, 미국, 31403-3089
- Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
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Hawaii
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'Aiea, Hawaii, 미국, 96701
- Kapiolani Medical Center at Pali Momi
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Honolulu, Hawaii, 미국, 96817
- The Cancer Center of Hawaii-Liliha
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Honolulu, Hawaii, 미국, 96813
- Cancer Research Center of Hawaii
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Honolulu, Hawaii, 미국, 96826
- Kapiolani Medical Center for Women and Children
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Honolulu, Hawaii, 미국, 96813
- OnCare Hawaii, Incorporated - Lusitana
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Honolulu, Hawaii, 미국, 96813
- Queen's Cancer Institute at Queen's Medical Center
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Honolulu, Hawaii, 미국, 96813
- Straub Clinic and Hospital, Incorporated
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Honolulu, Hawaii, 미국, 96817
- Hawaii Medical Center - East
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Honolulu, Hawaii, 미국, 96813
- University of Hawaii
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Honolulu, Hawaii, 미국, 96813
- Oncare Hawaii Inc-POB II
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Honolulu, Hawaii, 미국, 96817
- OnCare Hawaii-Liliha
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Honolulu, Hawaii, 미국, 96817-3169
- OnCare Hawaii, Incorporated - Kuakini
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Kailua, Hawaii, 미국, 96734
- Castle Medical Center
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Lihue, Hawaii, 미국, 96766
- Kauai Medical Clinic
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Wailuku, Hawaii, 미국, 96793
- Maui Memorial Medical Center
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Wailuku, Hawaii, 미국, 96793
- Pacific Cancer Institute - Maui
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Idaho
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Boise, Idaho, 미국, 83706
- Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
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Lewiston, Idaho, 미국, 83501
- Saint Joseph Regional Medical Center
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Illinois
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Aurora, Illinois, 미국, 60504
- Rush-Copley Cancer Care Center
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Bloomington, Illinois, 미국, 61701
- Illinois CancerCare - Bloomington
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Bloomington, Illinois, 미국, 61701
- St. Joseph Medical Center
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Canton, Illinois, 미국, 61520
- Illinois CancerCare - Canton
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Carthage, Illinois, 미국, 62321
- Illinois CancerCare - Carthage
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Chicago, Illinois, 미국, 60637-1470
- University of Chicago Cancer Research Center
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Chicago, Illinois, 미국, 60612-7243
- University of Illinois Cancer Center
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Chicago, Illinois, 미국, 60631
- Resurrection Medical Center
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Eureka, Illinois, 미국, 61530
- Illinois CancerCare - Eureka
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Eureka, Illinois, 미국, 61530
- Eureka Community Hospital
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Evanston, Illinois, 미국, 60201-1781
- Evanston Hospital
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Galesburg, Illinois, 미국, 61401
- Galesburg Clinic, PC
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Havana, Illinois, 미국, 62644
- Illinois CancerCare - Havana
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Kewanee, Illinois, 미국, 61443
- Illinois CancerCare - Kewanee Clinic
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La Grange, Illinois, 미국, 60525
- La Grange Memorial Hospital
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Macomb, Illinois, 미국, 61455
- Illinois CancerCare - Macomb
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Moline, Illinois, 미국, 61265
- Garneau, Stewart C MD (UIA Investigator)
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Moline, Illinois, 미국, 61265
- Spector, David MD (UIA Investigator)
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Moline, Illinois, 미국, 61265
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
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Moline, Illinois, 미국, 61265
- Porubcin, Michael (UIA Investigator)
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Monmouth, Illinois, 미국, 61462
- Illinois CancerCare - Monmouth
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Monmouth, Illinois, 미국, 61462
- OSF Holy Family Medical Center
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Naperville, Illinois, 미국, 60540
- Hematology Oncology Consultants - Naperville
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Normal, Illinois, 미국, 61761
- Bromenn Regional Medical Center
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Normal, Illinois, 미국, 61761
- Community Cancer Center
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Normal, Illinois, 미국, 61761
- Illinois CancerCare - Community Cancer Center
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Oak Lawn, Illinois, 미국, 60453-2699
- Advocate Christ Medical Center
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Ottawa, Illinois, 미국, 61350
- Illinois CancerCare-Ottawa Clinic
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Ottawa, Illinois, 미국, 61350
- Ottawa Regional Hospital and Healthcare Center
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Ottawa, Illinois, 미국, 61350
- Community Hospital of Ottawa
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Ottawa, Illinois, 미국, 61350
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
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Pekin, Illinois, 미국, 61554
- Pekin Cancer Treatment Center
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Pekin, Illinois, 미국, 61554
- Cancer Treatment Center at Pekin Hospital
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Pekin, Illinois, 미국, 61603
- Illinois CancerCare - Pekin
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Peoria, Illinois, 미국, 61615
- Illinois CancerCare-Peoria
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Peoria, Illinois, 미국, 61614
- Proctor Hospital
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Peoria, Illinois, 미국, 61603
- Methodist Medical Center of Illinois
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Peoria, Illinois, 미국, 61637
- OSF St. Francis Medical Center
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Peoria, Illinois, 미국, 61615
- CCOP - Illinois Oncology Research Association
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Peoria, Illinois, 미국, 61615
- Oncology Hematology Associates of Central Illinois, PC - Peoria
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Peru, Illinois, 미국, 61354
- Illinois CancerCare - Peru
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Peru, Illinois, 미국, 61354
- Illinois Valley Community Hospital
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Princeton, Illinois, 미국, 61356
- Illinois CancerCare - Princeton
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Rockford, Illinois, 미국, 61104-2315
- Swedish-American Regional Cancer Center
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Spring Valley, Illinois, 미국, 61362
- Illinois CancerCare - Spring Valley
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Urbana, Illinois, 미국, 61801
- CCOP - Carle Cancer Center
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Indiana
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Indianapolis, Indiana, 미국, 46237
- St. Francis Hospital Cancer Care Services
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Michigan City, Indiana, 미국, 46360
- Saint Anthony Memorial Health Centers
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Richmond, Indiana, 미국, 47374
- Reid Hospital & Health Care Services
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Iowa
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Ames, Iowa, 미국, 50010
- McFarland Clinic, PC
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Bettendorf, Iowa, 미국, 52722
- Constantinou, Costas L MD (UIA Investigator)
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Bettendorf, Iowa, 미국, 52722
- Hematology Oncology Associates of the Quad Cities
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Cedar Rapids, Iowa, 미국, 52402
- St. Luke's Hospital
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Cedar Rapids, Iowa, 미국, 52403
- Mercy Regional Cancer Center at Mercy Medical Center
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Cedar Rapids, Iowa, 미국, 52402
- Iowa Blood and Cancer Care
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Cedar Rapids, Iowa, 미국, 52402
- Helen G Nassif Community Cancer Center
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Clive, Iowa, 미국, 50325
- Medical Oncology and Hematology Associates - West Des Moines
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Clive, Iowa, 미국, 50325
- Mercy Cancer Center - West Lakes
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Davenport, Iowa, 미국, 52803
- Genesis Regional Cancer Center at Genesis Medical Center
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Des Moines, Iowa, 미국, 50309
- CCOP - Iowa Oncology Research Association
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Des Moines, Iowa, 미국, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
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Des Moines, Iowa, 미국, 50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
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Des Moines, Iowa, 미국, 50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
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Des Moines, Iowa, 미국, 50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
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Des Moines, Iowa, 미국, 50316
- John Stoddard Cancer Center at Iowa Lutheran Hospital
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Iowa City, Iowa, 미국, 52242-1002
- Holden Comprehensive Cancer Center at University of Iowa
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Iowa City, Iowa, 미국, 52246
- Veterans Affairs Medical Center - Iowa City
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Mason City, Iowa, 미국, 50401
- Mercy Cancer Center at Mercy Medical Center - North Iowa
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Ottumwa, Iowa, 미국, 52501
- McCreery Cancer Center at Ottumwa Regional
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Sioux City, Iowa, 미국, 51101
- Siouxland Hematology-Oncology Associates, LLP
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Sioux City, Iowa, 미국, 51102
- Mercy Medical Center - Sioux City
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Sioux City, Iowa, 미국, 51104
- St. Luke's Regional Medical Center
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West Des Moines, Iowa, 미국, 50266-7700
- Methodist West Hospital
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Kansas
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Topeka, Kansas, 미국, 66604
- Stormont-Vail Regional Health Center
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Kentucky
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Lexington, Kentucky, 미국, 40503-9985
- Central Baptist Hospital
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Louisiana
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Baton Rouge, Louisiana, 미국, 70809
- Mary Bird Perkins Cancer Center - Baton Rouge
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Monroe, Louisiana, 미국, 71210
- Louisiana State University Health Sciences Center - Monroe
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New Orleans, Louisiana, 미국, 70112
- Louisiana State University Health Science Center
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New Orleans, Louisiana, 미국, 70112
- Interim LSU Public Hospital
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Shreveport, Louisiana, 미국, 71105
- Highland Clinic
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Shreveport, Louisiana, 미국, 71130-3932
- Feist-Weiller Cancer Center at Louisiana State University Health Sciences
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Maine
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Augusta, Maine, 미국, 04330
- Harold Alfond Center for Cancer Care
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Bangor, Maine, 미국, 04401
- Eastern Maine Medical Center
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Bangor, Maine, 미국, 04401
- CancerCare of Maine at Eastern Maine Medical Center
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Maryland
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Baltimore, Maryland, 미국, 21201
- Veterans Affairs Medical Center - Baltimore
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Baltimore, Maryland, 미국, 21215
- Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
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Baltimore, Maryland, 미국, 21201
- Greenebaum Cancer Center at University of Maryland Medical Center
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Bethesda, Maryland, 미국, 20889-5600
- National Naval Medical Center
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Elkton, Maryland, 미국, 21921
- Union Hospital of Cecil County
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Hagerstown, Maryland, 미국, 21742
- Meritus Medical Center
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Hagerstown, Maryland, 미국, 21740
- John R. Marsh Cancer Center at Washington County Hospital
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Massachusetts
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Beverly, Massachusetts, 미국, 01915
- Beverly Hospital
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Boston, Massachusetts, 미국, 02118
- Boston University Cancer Research Center
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Boston, Massachusetts, 미국, 02115
- Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
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Brighton, Massachusetts, 미국, 02135-2997
- Caritas St. Elizabeth's Medical Center
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Gloucester, Massachusetts, 미국, 01930
- Addison Gilbert Hospital
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Milford, Massachusetts, 미국, 01757
- Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center
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South Weymouth, Massachusetts, 미국, 02190
- Dana-Farber/Brigham and Women's Cancer Center at South Shore
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Michigan
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Adrian, Michigan, 미국, 49221
- Hickman Cancer Center at Bixby Medical Center
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Adrian, Michigan, 미국, 49221
- Toledo Clinic Cancer Centers - Adrian
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Ann Arbor, Michigan, 미국, 48106-0995
- Saint Joseph Mercy Cancer Center
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Ann Arbor, Michigan, 미국, 48106
- CCOP - Michigan Cancer Research Consortium
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Battle Creek, Michigan, 미국, 49017
- Battle Creek Health System Cancer Care Center
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Big Rapids, Michigan, 미국, 49307
- Mecosta County Medical Center
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Dearborn, Michigan, 미국, 48124
- Oakwood Hospital
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Dearborn, Michigan, 미국, 48124
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
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Detroit, Michigan, 미국, 48236
- Saint John Hospital and Medical Center
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Escanaba, Michigan, 미국, 49431
- Green Bay Oncology, Limited - Escanaba
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Flint, Michigan, 미국, 48503
- Hurley Medical Center
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Flint, Michigan, 미국, 48503
- Genesys Hurley Cancer Institute
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Grand Blanc, Michigan, 미국, 48439
- Genesys Regional Medical Center
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Grand Rapids, Michigan, 미국, 49503
- Spectrum Health at Butterworth Campus
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Grand Rapids, Michigan, 미국, 49503
- Butterworth Hospital at Spectrum Health
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Grand Rapids, Michigan, 미국, 49503
- CCOP - Grand Rapids
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Grand Rapids, Michigan, 미국, 49503
- Lacks Cancer Center at Saint Mary's Health Care
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Grosse Pointe Woods, Michigan, 미국, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Iron Mountain, Michigan, 미국, 49801
- Dickinson County Healthcare System
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Iron Mountain, Michigan, 미국, 49801
- Green Bay Oncology - Iron Mountain
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Jackson, Michigan, 미국, 49201
- Allegiance Health
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Jackson, Michigan, 미국, 49201
- Foote Memorial Hospital
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Kalamazoo, Michigan, 미국, 49007
- Bronson Methodist Hospital
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Kalamazoo, Michigan, 미국, 49001
- Borgess Medical Center
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Kalamazoo, Michigan, 미국, 49007-3731
- West Michigan Cancer Center
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Lansing, Michigan, 미국, 48912-1811
- Sparrow Regional Cancer Center
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Livonia, Michigan, 미국, 48154
- St. Mary Mercy Hospital
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Monroe, Michigan, 미국, 48162
- Community Cancer Center of Monroe
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Monroe, Michigan, 미국, 48162
- Mercy Memorial Hospital - Monroe
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Monroe, Michigan, 미국, 48162
- Toledo Clinic Cancer Centers - Monroe
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Muskegon, Michigan, 미국, 49444
- Mercy General Health Partners
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Pontiac, Michigan, 미국, 48341-2985
- St. Joseph Mercy Oakland
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Port Huron, Michigan, 미국, 48060
- Mercy Regional Cancer Center at Mercy Hospital
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Reed City, Michigan, 미국, 49677
- Spectrum Health Reed City Hospital
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Saginaw, Michigan, 미국, 48601
- Seton Cancer Institute at Saint Mary's - Saginaw
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Southfield, Michigan, 미국, 48075
- Providence Cancer Institute at Providence Hospital - Southfield Campus
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Traverse City, Michigan, 미국, 49684
- Munson Medical Center
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Warren, Michigan, 미국, 48093
- St. John Macomb Hospital
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Minnesota
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Bemidji, Minnesota, 미국, 56601
- Sanford Clinic North-Bemidji
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Brainerd, Minnesota, 미국, 56401
- St. Joseph's Medical Center
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Burnsville, Minnesota, 미국, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, 미국, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
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Duluth, Minnesota, 미국, 55805
- CCOP - Duluth
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Duluth, Minnesota, 미국, 55805
- Miller - Dwan Medical Center
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Duluth, Minnesota, 미국, 55805-1983
- Essentia Health - Duluth Clinic
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Edina, Minnesota, 미국, 55435
- Fairview Southdale Hospital
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Fridley, Minnesota, 미국, 55432
- Mercy and Unity Cancer Center at Unity Hospital
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Hutchinson, Minnesota, 미국, 55350
- Hutchinson Area Health Care
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Maplewood, Minnesota, 미국, 55109
- HealthEast Cancer Care at St. John's Hospital
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Maplewood, Minnesota, 미국, 55109
- Minnesota Oncology - Maplewood
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Minneapolis, Minnesota, 미국, 55407
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
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Minneapolis, Minnesota, 미국, 55455
- Masonic Cancer Center at University of Minnesota
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Minneapolis, Minnesota, 미국, 55415
- Hennepin County Medical Center - Minneapolis
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New Ulm, Minnesota, 미국, 56073
- New Ulm Medical Center
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Robbinsdale, Minnesota, 미국, 55422-2900
- Humphrey Cancer Center at North Memorial Outpatient Center
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Saint Louis Park, Minnesota, 미국, 55416
- CCOP - Metro-Minnesota
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Saint Louis Park, Minnesota, 미국, 55416
- Park Nicollet Cancer Center
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Saint Paul, Minnesota, 미국, 55102
- United Hospital
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Saint Paul, Minnesota, 미국, 55101
- Regions Hospital Cancer Care Center
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Shakopee, Minnesota, 미국, 55379
- St. Francis Cancer Center at St. Francis Medical Center
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Stillwater, Minnesota, 미국, 55082
- Lakeview Hospital
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Waconia, Minnesota, 미국, 55387
- Ridgeview Medical Center
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Willmar, Minnesota, 미국, 56201
- Willmar Cancer Center at Rice Memorial Hospital
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Woodbury, Minnesota, 미국, 55125
- Minnesota Oncology - Woodbury
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Mississippi
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Jackson, Mississippi, 미국, 39216
- University of Mississippi Cancer Clinic
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Pascagoula, Mississippi, 미국, 39581
- Regional Cancer Center at Singing River Hospital
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Missouri
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Bolivar, Missouri, 미국, 65613
- Central Care Cancer Center at Carrie J. Babb Cancer Center
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Branson, Missouri, 미국, 65616
- Cox Cancer Center Branson
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Branson, Missouri, 미국, 65616
- Skaggs Cancer Center at Skaggs Regional Medical Center
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Cape Girardeau, Missouri, 미국, 63703
- Southeast Cancer Center
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Columbia, Missouri, 미국, 65203
- Ellis Fischel Cancer Center at University of Missouri - Columbia
-
Columbia, Missouri, 미국, 65201
- Veterans Administration/Harry S Truman Memorial Hospital
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Jefferson City, Missouri, 미국, 65109
- Goldschmidt Cancer Center
-
Saint Louis, Missouri, 미국, 63110
- Washington University School of Medicine
-
Saint Louis, Missouri, 미국, 63131
- Missouri Baptist Cancer Center
-
Saint Louis, Missouri, 미국, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
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Springfield, Missouri, 미국, 65804
- St. John's Regional Health Center
-
Springfield, Missouri, 미국, 65807
- Hulston Cancer Center at Cox Medical Center South
-
Springfield, Missouri, 미국, 65804
- CCOP - Cancer Research for the Ozarks
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Springfield, Missouri, 미국, 65804
- Mercy-Springfield
-
-
Montana
-
Billings, Montana, 미국, 59101
- CCOP - Montana Cancer Consortium
-
Billings, Montana, 미국, 59101
- St. Vincent Healthcare Cancer Care Services
-
Billings, Montana, 미국, 59107-7000
- Billings Clinic - Downtown
-
Billings, Montana, 미국, 59102
- Hematology-Oncology Centers of the Northern Rockies - Billings
-
Bozeman, Montana, 미국, 59715
- Bozeman Deaconess Cancer Center
-
Butte, Montana, 미국, 59701
- St. James Healthcare Cancer Care
-
Great Falls, Montana, 미국, 59405
- Great Falls Clinic - Main Facility
-
Great Falls, Montana, 미국, 59405-5309
- Big Sky Oncology
-
Great Falls, Montana, 미국, 59405
- Benefis Sletten Cancer Institute
-
Helena, Montana, 미국, 59601
- St. Peter's Hospital
-
Kalispell, Montana, 미국, 59901
- Kalispell Regional Medical Center
-
Missoula, Montana, 미국, 59807-7877
- Montana Cancer Specialists at Montana Cancer Center
-
Missoula, Montana, 미국, 59807
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
-
-
Nebraska
-
Kearney, Nebraska, 미국, 68848-1990
- Good Samaritan Cancer Center at Good Samaritan Hospital
-
-
Nevada
-
Reno, Nevada, 미국, 89502
- Renown Institute for Cancer at Renown Regional Medical Center
-
-
New Hampshire
-
Concord, New Hampshire, 미국, 03301
- New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
-
Exeter, New Hampshire, 미국, 03833
- Center for Cancer Care at Exeter Hospital
-
Hooksett, New Hampshire, 미국, 03106
- New Hampshire Oncology - Hematology, PA - Hooksett
-
Laconia, New Hampshire, 미국, 03246
- Lakes Region General Hospital
-
Lebanon, New Hampshire, 미국, 03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
-
Londonderry, New Hampshire, 미국, 03053
- Dana-Farber Cancer Institute at Londonderry
-
Manchester, New Hampshire, 미국, 03102
- Norris Cotton Cancer Center-Manchester
-
-
New Jersey
-
Camden, New Jersey, 미국, 08103
- Cooper Hospital University Medical Center
-
East Orange, New Jersey, 미국, 07018
- Veterans Administration New Jersey Health Care System
-
Newark, New Jersey, 미국, 07112
- Newark Beth Israel Medical Center
-
Ridgewood, New Jersey, 미국, 07450
- Valley Hospital - Ridgewood
-
Voorhees, New Jersey, 미국, 08043
- Cancer Institute of New Jersey at Cooper - Voorhees
-
-
New York
-
Brooklyn, New York, 미국, 11209
- Veterans Affairs Medical Center - Brooklyn
-
Buffalo, New York, 미국, 14215
- Veterans Affairs Medical Center - Buffalo
-
East Syracuse, New York, 미국, 13057
- CCOP - Hematology-Oncology Associates of Central New York
-
Glens Falls, New York, 미국, 12801
- Charles R. Wood Cancer Center at Glens Falls Hospital
-
Lake Success, New York, 미국, 11042
- Monter Cancer Center of the North Shore-LIJ Health System
-
Manhasset, New York, 미국, 11030
- CCOP - North Shore University Hospital
-
Manhasset, New York, 미국, 11030
- Don Monti Comprehensive Cancer Center at North Shore University Hospital
-
Middletown, New York, 미국, 10940
- Orange Regional Medical Center
-
New Hyde Park, New York, 미국, 11040
- Long Island Jewish Medical Center
-
New York, New York, 미국, 10021
- New York Weill Cornell Cancer Center at Cornell University
-
Rochester, New York, 미국, 14621
- Lipson Cancer and Blood Center at Rochester General Hospital
-
Syracuse, New York, 미국, 13210
- Veterans Affairs Medical Center - Syracuse
-
Syracuse, New York, 미국, 13210
- SUNY Upstate Medical University Hospital
-
-
North Carolina
-
Asheville, North Carolina, 미국, 28801
- Mission Hospitals - Memorial Campus
-
Durham, North Carolina, 미국, 27705
- Veterans Affairs Medical Center - Durham
-
Durham, North Carolina, 미국, 27710
- Duke Cancer Institute
-
Goldsboro, North Carolina, 미국, 27534
- Wayne Memorial Hospital, Incorporated
-
Kinston, North Carolina, 미국, 28501
- Kinston Medical Specialists
-
Lumberton, North Carolina, 미국, 28359
- Southeastern Regional Medical Center
-
Oxford, North Carolina, 미국, 27565
- Granville Medical Center
-
Pinehurst, North Carolina, 미국, 28374
- FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
-
Raleigh, North Carolina, 미국, 27609
- Duke Health Raleigh Hospital
-
Roxboro, North Carolina, 미국, 27573
- Person Memorial Hospital
-
Statesville, North Carolina, 미국, 28677
- Iredell Memorial Hospital
-
Washington, North Carolina, 미국, 27889
- Marion L. Shepard Cancer Center at Beaufort County Hospital
-
-
North Dakota
-
Bismarck, North Dakota, 미국, 58501
- Sanford Bismarck Medical Center
-
Bismarck, North Dakota, 미국, 58501
- Medcenter One Hospital Cancer Care Center
-
Bismarck, North Dakota, 미국, 58501
- Mid Dakota Clinic, PC
-
Bismarck, North Dakota, 미국, 58502
- St. Alexius Medical Center Cancer Center
-
Fargo, North Dakota, 미국, 58122
- Sanford Roger Maris Cancer Center
-
Fargo, North Dakota, 미국, 58103
- Essentia Health Cancer Center-South University Clinic
-
Fargo, North Dakota, 미국, 58122
- Sanford Clinic North-Fargo
-
Fargo, North Dakota, 미국, 58102
- Sanford Clinic North-Fargo
-
Fargo, North Dakota, 미국, 58103
- Dakota Cancer Institute at Dakota Clinic - South University
-
Grand Forks, North Dakota, 미국, 58201
- Altru Cancer Center at Altru Hospital
-
Minot, North Dakota, 미국, 58701
- Trinity CancerCare Center
-
-
Ohio
-
Bowling Green, Ohio, 미국, 43402
- Wood County Oncology Center
-
Cincinnati, Ohio, 미국, 45267
- Charles M. Barrett Cancer Center at University Hospital
-
Columbus, Ohio, 미국, 43210-1240
- Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
-
Dayton, Ohio, 미국, 45405
- Grandview Hospital
-
Dayton, Ohio, 미국, 45406
- Good Samaritan Hospital
-
Dayton, Ohio, 미국, 45409
- David L. Rike Cancer Center at Miami Valley Hospital
-
Dayton, Ohio, 미국, 45415
- Samaritan North Cancer Care Center
-
Dayton, Ohio, 미국, 45420
- Dayton CCOP
-
Dayton, Ohio, 미국, 45420
- CCOP - Dayton
-
Elyria, Ohio, 미국, 44035
- Community Cancer Center
-
Elyria, Ohio, 미국, 44035
- Hematology Oncology Center
-
Findlay, Ohio, 미국, 45840
- Blanchard Valley Medical Associates
-
Franklin, Ohio, 미국, 45005-1066
- Middletown Regional Hospital
-
Greenville, Ohio, 미국, 45331
- Wayne Hospital
-
Kettering, Ohio, 미국, 45429
- Charles F. Kettering Memorial Hospital
-
Lima, Ohio, 미국, 45804
- Lima Memorial Hospital
-
Lima, Ohio, 미국, 45801
- St. Rita's Medical Center
-
Maumee, Ohio, 미국, 43537-1839
- Northwest Ohio Oncology Center
-
Maumee, Ohio, 미국, 43537
- Toledo Clinic Cancers Centers - Maumee
-
Oregon, Ohio, 미국, 43616
- St. Charles Mercy Hospital
-
Oregon, Ohio, 미국, 43616
- Toledo Clinic - Oregon
-
Sylvania, Ohio, 미국, 43560
- Flower Hospital Cancer Center
-
Tiffin, Ohio, 미국, 44883
- Mercy Hospital of Tiffin
-
Toledo, Ohio, 미국, 43614
- University of Toledo
-
Toledo, Ohio, 미국, 43608
- St. Vincent Mercy Medical Center
-
Toledo, Ohio, 미국, 43606
- Toledo Hospital
-
Toledo, Ohio, 미국, 43614
- Medical University of Ohio Cancer Center
-
Toledo, Ohio, 미국, 43617
- CCOP - Toledo Community Hospital
-
Toledo, Ohio, 미국, 43623
- Toledo Clinic, Incorporated - Main Clinic
-
Toledo, Ohio, 미국, 43623
- St. Anne Mercy Hospital
-
Troy, Ohio, 미국, 45373-1300
- UVMC Cancer Care Center at Upper Valley Medical Center
-
Wauseon, Ohio, 미국, 43567
- Fulton County Health Center
-
Xenia, Ohio, 미국, 45385
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
-
-
Oklahoma
-
Lawton, Oklahoma, 미국, 73505
- Cancer Centers of Southwest Oklahoma, LLC - Lawton
-
Norman, Oklahoma, 미국, 73071
- Mercy Clinic Oklahoma Communities Inc-Norman
-
Oklahoma City, Oklahoma, 미국, 73104
- Oklahoma University Cancer Institute
-
Oklahoma City, Oklahoma, 미국, 73120
- Mercy Clinic Oklahoma Communities Inc-Mercy Health Center
-
-
Oregon
-
The Dalles, Oregon, 미국, 97058
- Celilo Cancer Center at Mid-Columbia Medical Center
-
-
Pennsylvania
-
Abington, Pennsylvania, 미국, 19001
- Rosenfeld Cancer Center at Abington Memorial Hospital
-
-
Rhode Island
-
Providence, Rhode Island, 미국, 02906
- Miriam Hospital
-
Providence, Rhode Island, 미국, 02903
- Rhode Island Hospital Comprehensive Cancer Center
-
-
South Carolina
-
Florence, South Carolina, 미국, 29501
- McLeod Regional Medical Center
-
-
South Dakota
-
Rapid City, South Dakota, 미국, 57701
- Rapid City Regional Hospital
-
-
Tennessee
-
Kingsport, Tennessee, 미국, 37662
- Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
-
-
Vermont
-
White River Junction, Vermont, 미국, 05009
- Veterans Affairs Medical Center - White River Junction
-
White River Junction, Vermont, 미국, 05009
- White River Junction Veteran Administration Medical Center
-
-
Virginia
-
Danville, Virginia, 미국, 24541
- Danville Regional Medical Center
-
Fredericksburg, Virginia, 미국, 22401
- Fredericksburg Oncology, Incorporated
-
Lynchburg, Virginia, 미국, 24501
- Lynchburg Hematology-Oncology Clinic
-
Martinsville, Virginia, 미국, 24115
- Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
-
Norton, Virginia, 미국, 24273
- Southwest Virginia Regional Cancer Center at Wellmonth Health
-
-
Washington
-
Anacortes, Washington, 미국, 98221
- Island Hospital Cancer Care Center at Island Hospital
-
Auburn, Washington, 미국, 98002
- Auburn Regional Center for Cancer Care
-
Bellevue, Washington, 미국, 98004
- Overlake Cancer Center at Overlake Hospital Medical Center
-
Bellingham, Washington, 미국, 98225
- St. Joseph Cancer Center
-
Bremerton, Washington, 미국, 98310
- Olympic Hematology and Oncology
-
Burien, Washington, 미국, 98166
- Highline Medical Center Cancer Center
-
Centralia, Washington, 미국, 98531
- Providence Centralia Hospital
-
Edmonds, Washington, 미국, 98026
- Swedish Medical Center-Edmonds
-
Everett, Washington, 미국, 98201
- Providence Regional Cancer Partnership
-
Federal Way, Washington, 미국, 98003
- Saint Francis Hospital
-
Issaquah, Washington, 미국, 98029
- Swedish Medical Center - Issaquah Campus
-
Kennewick, Washington, 미국, 99336
- Columbia Basin Hematology
-
Mount Vernon, Washington, 미국, 98274
- Skagit Valley Hospital Cancer Care Center
-
Olympia, Washington, 미국, 98506-5166
- Providence St. Peter Hospital Regional Cancer Center
-
Poulsbo, Washington, 미국, 98370
- Harrison Poulsbo Hematology and Onocology
-
Puyallup, Washington, 미국, 98372
- Good Samaritan Cancer Center
-
Seattle, Washington, 미국, 98109
- Fred Hutchinson Cancer Research Center
-
Seattle, Washington, 미국, 98104
- Harborview Medical Center
-
Seattle, Washington, 미국, 98112
- Group Health Central Hospital
-
Seattle, Washington, 미국, 98122-4307
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
-
Seattle, Washington, 미국, 98195
- University Cancer Center at University of Washington Medical Center
-
Sedro-Woolley, Washington, 미국, 98284
- North Puget Oncology at United General Hospital
-
Spokane, Washington, 미국, 99202
- Cancer Care Northwest - Spokane South
-
Spokane, Washington, 미국, 99218
- Evergreen Hematology and Oncology, PS
-
Tacoma, Washington, 미국, 98405
- Saint Joseph Medical Center
-
Tacoma, Washington, 미국, 98405
- Allenmore Hospital
-
Tacoma, Washington, 미국, 98405
- Northwest CCOP
-
Tacoma, Washington, 미국, 98499
- Saint Clare Hospital
-
Tacoma, Washington, 미국, 98415
- Multicare Health System - Tacoma General Hospital
-
Wenatchee, Washington, 미국, 98801-2028
- Wenatchee Valley Medical Center
-
-
West Virginia
-
Huntington, West Virginia, 미국, 25701
- Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
-
Morgantown, West Virginia, 미국, 26506
- Mary Babb Randolph Cancer Center at West Virginia University Hospitals
-
-
Wisconsin
-
Chippewa Falls, Wisconsin, 미국, 54729
- Marshfield Clinic - Chippewa Center
-
Eau Claire, Wisconsin, 미국, 54701
- Marshfield Clinic Cancer Care at Regional Cancer Center
-
Green Bay, Wisconsin, 미국, 54307-3508
- St. Vincent Hospital Regional Cancer Center
-
Green Bay, Wisconsin, 미국, 54301-3526
- Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
-
Green Bay, Wisconsin, 미국, 54303
- Green Bay Oncology, Limited at St. Mary's Hospital
-
Green Bay, Wisconsin, 미국, 54303
- St. Mary's Hospital Medical Center - Green Bay
-
Janesville, Wisconsin, 미국, 53547
- Mercy Regional Cancer Center
-
La Crosse, Wisconsin, 미국, 54601
- Gundersen Lutheran Center for Cancer and Blood
-
Manitowoc, Wisconsin, 미국, 54221-1450
- Holy Family Memorial Medical Center Cancer Care Center
-
Marinette, Wisconsin, 미국, 54143
- Bay Area Cancer Care Center at Bay Area Medical Center
-
Marshfield, Wisconsin, 미국, 54449
- Marshfield Clinic - Marshfield Center
-
Minocqua, Wisconsin, 미국, 54548
- Marshfield Clinic - Minocqua Center
-
Mukwonago, Wisconsin, 미국, 53149
- D.N. Greenwald Center
-
New Richmond, Wisconsin, 미국, 54017
- Westfields Hospital/Cancer Center of Western Wisconsin
-
Oconomowoc, Wisconsin, 미국, 53066
- Regional Cancer Center at Oconomowoc Memorial Hospital
-
Oconto Falls, Wisconsin, 미국, 54154
- Green Bay Oncology, Limited - Oconto Falls
-
Rhinelander, Wisconsin, 미국, 54501
- Marshfield Clinic at James Beck Cancer Center
-
Rhinelander, Wisconsin, 미국, 54501
- Ministry Medical Group at Saint Mary's Hospital
-
Rice Lake, Wisconsin, 미국, 54868
- Marshfield Clinic - Rice Lake Center
-
Sheboygan, Wisconsin, 미국, 53081
- St. Nicholas Hospital
-
Stevens Point, Wisconsin, 미국, 54481
- Marshfield Clinic at Saint Michael's Hospital
-
Sturgeon Bay, Wisconsin, 미국, 54235
- Green Bay Oncology, Limited - Sturgeon Bay
-
Waukesha, Wisconsin, 미국, 53188
- Waukesha Memorial Hospital Regional Cancer Center
-
Weston, Wisconsin, 미국, 54476
- Diagnostic and Treatment Center
-
Weston, Wisconsin, 미국, 54476
- Marshfield Clinic - Weston Center
-
Wisconsin Rapids, Wisconsin, 미국, 54494
- Marshfield Clinic - Wisconsin Rapids Center
-
-
Wyoming
-
Casper, Wyoming, 미국, 82609
- Rocky Mountain Oncology
-
Sheridan, Wyoming, 미국, 82801
- Welch Cancer Center at Sheridan Memorial Hospital
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell carcinoma of the lung, including the following cell types:
- Adenocarcinoma
- Large cell carcinoma
- Squamous cell carcinoma
- Mixture of these types
- A tissue block must be available at the time of registration
- Tumor expresses COX-2 (COX-2 index ≥ 2)
Stage IIIB disease with malignant pleural effusion, supraclavicular node involvement, or contralateral hilar node involvement OR stage IV disease
- Patients with stage IIIB disease who are eligible for clinical trials that involve combined chemotherapy and chest irradiation are not eligible for this study
- Patients with stage IV disease are eligible
- Patients with recurrent disease, not amenable to (or refusing) a potentially "curative therapy," are eligible
Measurable or non-measurable disease
- Measurable disease is defined as lesions that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 2 cm with conventional techniques or as ≥ 1 cm with spiral CT scan
Non-measurable disease is defined as all other lesions, including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan) and truly nonmeasurable lesions, including any of the following:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Inflammatory breast disease
- Lymphangitis cutis/pulmonis
- Abdominal masses that are not confirmed and followed by imaging techniques
- Cystic lesions
Patients with symptomatic CNS metastases are eligible provided they received prior therapy (e.g., surgery, radiotherapy, or gamma knife), are neurologically stable, and are off steroids for ≥ 14 days before study entry
- Patients with asymptomatic CNS metastases without associated edema, shift, or requirement for steroids or antiseizure medications may be eligible after discussion with the Study Chair
- Patients should be off steroids at least 7 days before preregistration
- No leptomeningeal disease or carcinomatous meningitis
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Granulocytes ≥ 1,500/μL
- Platelet count ≥ 100,000/μL
- Creatinine clearance ≥ 45 mL/min
- Bilirubin ≤ 1.5 mg/dL
- AST and ALT ≤ 2.0 times upper limit of normal (ULN) (≤ 5.0 times ULN if liver metastases are present)
- Serum albumin ≥ 2.5 mg/dL
- Not pregnant or nursing
- Negative pregnancy test
No "currently active" second malignancy other than non-melanoma skin cancer
- Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at < 30% risk of relapse
- No known hypersensitivity to aspirin, NSAIDs, or sulfonamides
No active ulcer disease
- No history of gastrointestinal bleeding within the past three years
None of the following cardiovascular conditions within the past 6 months:
- Myocardial infarction
- Unstable angina
- Symptomatic congestive heart failure
- Serious uncontrolled cardiac arrhythmia
- Cerebrovascular accident or transient ischemic attack
- Pulmonary embolism
- Symptomatic carotid artery or peripheral vascular disease
- Deep vein thrombosis
- Other significant thromboembolic event
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemotherapy, immunotherapy, or other systemic therapy for non-small cell lung cancer, including adjuvant therapy
- At least 2 weeks since prior surgery and recovered
- At least 7 days since prior radiotherapy
At least 14 days since prior NSAIDs (other than low-dose aspirin [≤ 325 mg daily]), including any of the following:
- Celecoxib
- Choline Mg
- Trisalicylate (Trilisate®)
- Ibuprofen (Advil® or Motrin®)
- Naproxen (Aleve®, Naprosyn® or Anaprox®)
- Etodolac (Lodine®)
- Oxaprozin (Daypro®)
- Diflunisal (Dolobid®)
- Nabumetone (Relafen®)
- Tolmetin (Tolectin®)
- Valdecoxib (Bextra®)
No chronic use of NSAIDs (i.e., > 4 weeks of daily use)
- Patients on low-dose aspirin are eligible
- No other concurrent chemotherapy or hormonal therapy (other than megestrol acetate [Megace] for appetite stimulation)
- No other concurrent investigational therapy
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Arm I
Patients receive gemcitabine hydrochloride* IV on days 1 and 8 OR pemetrexed disodium* IV on day 1.
Patients also receive carboplatin IV on day 1 and oral celecoxib twice daily on days 1-21.
|
주어진 IV
주어진 IV
주어진 IV
구두로 주어진
|
|
활성 비교기: Arm II
Patients receive gemcitabine hydrochloride* OR pemetrexed disodium* and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 1-21.
|
구두로 주어진
주어진 IV
주어진 IV
주어진 IV
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Progression-free Survival
기간: Time between randomization and disease relapse or death from any cause, assessed up to 5 years
|
Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first.
Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
|
Time between randomization and disease relapse or death from any cause, assessed up to 5 years
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Overall Survival
기간: Time between randomization and death from any cause, assessed up to 5 years
|
Overall survival time is defined as the time from randomization to death due to any cause.
The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
|
Time between randomization and death from any cause, assessed up to 5 years
|
|
Response Rate
기간: Up to 5 years
|
The response rate (percentage) is the percent of patients whose best response was Complete Response (CR) or Partial Response (PR) as defined by RECIST 1.1 criteria.
Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients.
Response rates (including complete and partial response) will be tested using Fisher's exact test
|
Up to 5 years
|
|
Incidence of Toxicities as Assessed by NCI CTCAE v. 4.0
기간: Up to 5 years
|
The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment
|
Up to 5 years
|
|
Prognostic Value of Urinary Prostaglandin Metabolites (PGE-M) Levels for Worse PFS for Patients Who Had Baseline Urinary PGE-M Above/Below the First Quartile (Q1)
기간: Up to 5 years
|
Prognostic value of urinary prostaglandin metabolites (PGE-M) levels for worse PFS for patients who had baseline urinary PGE-M above/below the first quartile (Q1, 10.09).
Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first.
Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
|
Up to 5 years
|
|
Prognostic Value of Urinary Prostaglandin Metabolites (PGE-M) Levels for Worse PFS for Patients Who Had Baseline Urinary PGE-M Above/Below the Median Quartile (Q2)
기간: Up to 5 years
|
prognostic value of urinary prostaglandin metabolites (PGE-M) levels for worse PFS for patients who had baseline urinary PGE-M above/below the median quartile (Q2, 15.38).
Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first.
Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
|
Up to 5 years
|
|
Prognostic Value of Urinary Prostaglandin Metabolites (PGE-M) Levels for Worse PFS for Patients Who Had Baseline Urinary PGE-M Above/Below the Third Quartile (Q3)
기간: Up to 5 years
|
Prognostic value of urinary prostaglandin metabolites (PGE-M) levels for worse PFS for patients who had baseline urinary PGE-M above/below the median quartile (Q3, 27.86).
Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first.
Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
|
Up to 5 years
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 의자: Martin J. Edelman, MD, University of Maryland Greenebaum Cancer Center
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Edelman MJ, Wang X, Hodgson L, Cheney RT, Baggstrom MQ, Thomas SP, Gajra A, Bertino E, Reckamp KL, Molina J, Schiller JH, Mitchell-Richards K, Friedman PN, Ritter J, Milne G, Hahn OM, Stinchcombe TE, Vokes EE; Alliance for Clinical Trials in Oncology. Phase III Randomized, Placebo-Controlled, Double-Blind Trial of Celecoxib in Addition to Standard Chemotherapy for Advanced Non-Small-Cell Lung Cancer With Cyclooxygenase-2 Overexpression: CALGB 30801 (Alliance). J Clin Oncol. 2017 Jul 1;35(19):2184-2192. doi: 10.1200/JCO.2016.71.3743. Epub 2017 May 10.
- Hamy AS, Tury S, Wang X, Gao J, Pierga JY, Giacchetti S, Brain E, Pistilli B, Marty M, Espie M, Benchimol G, Laas E, Lae M, Asselain B, Aouchiche B, Edelman M, Reyal F. Celecoxib With Neoadjuvant Chemotherapy for Breast Cancer Might Worsen Outcomes Differentially by COX-2 Expression and ER Status: Exploratory Analysis of the REMAGUS02 Trial. J Clin Oncol. 2019 Mar 10;37(8):624-635. doi: 10.1200/JCO.18.00636. Epub 2019 Jan 31.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2010년 2월 1일
기본 완료 (실제)
2017년 1월 17일
연구 완료 (실제)
2018년 3월 1일
연구 등록 날짜
최초 제출
2009년 12월 31일
QC 기준을 충족하는 최초 제출
2009년 12월 31일
처음 게시됨 (추정)
2010년 1월 1일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 7월 23일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 6월 26일
마지막으로 확인됨
2018년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CALGB-30801
- CDR0000662707 (레지스트리 식별자: NCI Physician Data Query)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .