Combination Chemotherapy and Intensity-Modulated Radiation Therapy in Treating Patients Undergoing Surgery for Locally Advanced Rectal Cancer
27. srpna 2018 aktualizováno: Radiation Therapy Oncology Group
A Phase II Evaluation of Preoperative Chemoradiotherapy Utilizing Intensity Modulated Radiation Therapy (IMRT) in Combination With Capecitabine and Oxaliplatin for Patients With Locally Advanced Rectal Cancer
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying the side effects and how well giving combination chemotherapy together with intensity-modulated radiation therapy works in treating patients undergoing surgery for locally advanced rectal cancer.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Detailní popis
OBJECTIVES:
Primary
- To determine whether the incidence of neoadjuvant acute gastrointestinal toxicity (grade ≥ 2) associated with neoadjuvant chemoradiotherapy is reduced by inverse-planned intensity-modulated radiotherapy (IMRT)-based radiation treatment when compared with conventionally delivered radiotherapy, as was utilized in the capecitabine and oxaliplatin arm of RTOG-0247 (NCT00081289).
Secondary
- To evaluate the feasibility of performing IMRT in a cooperative group setting for the treatment of rectal cancer.
- To estimate the incidence of all toxicity (hematologic and non-hematologic) associated with protocol treatment in the neoadjuvant period, the adjuvant period, and overall.
- To estimate the pathologic complete response rate following neoadjuvant IMRT-based chemoradiotherapy.
- To estimate the time to treatment failure and patterns of failure.
- To correlate pre- and post-treatment levels of serum cytokines with symptoms during and pathological outcomes following neoadjuvant chemoradiotherapy for rectal cancer.
- To evaluate the rate of abdominoperineal resections.
OUTLINE: This is a multicenter study.
- Chemoradiotherapy: Patients undergo inverse-planned intensity-modulated radiotherapy to the pelvis once daily, 5 days a week, for 5 weeks (total of 45 Gy) and a 3-dimensional conformal radiotherapy boost to gross disease once daily for 3 days (total of 45 Gy). Beginning on the first day of radiotherapy and continuing through completion of radiotherapy, patients receive oral capecitabine twice daily, 5 days a week, for 5 weeks and oxaliplatin IV over 2 hours on days 1, 8, 15, 22, 29.
- Surgery: Within 4-8 weeks after completion of chemoradiotherapy, patients undergo resection of the rectal tumor.
- Adjuvant chemotherapy: Beginning 4-8 weeks after surgery, patients with completely resected disease and negative surgical margins receive leucovorin calcium IV over 2 hours and oxaliplatin IV over 2 hours on day 1 and fluorouracil IV bolus on day 1 and fluorouracil IV infusion continuously over 46 hours beginning on day 1 . Treatment repeats every 14 days for up to 9 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months after the start of treatment for 2 years, every 6 months for years 3-5, and then annually thereafter.
Typ studie
Intervenční
Zápis (Aktuální)
79
Fáze
- Fáze 2
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Ontario
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London, Ontario, Kanada, N6A 4L6
- London Regional Cancer Program at London Health Sciences Centre
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Alabama
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Mobile, Alabama, Spojené státy, 36608
- Providence Cancer Center at Providence Hospital
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California
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Auburn, California, Spojené státy, 95603
- Auburn Radiation Oncology
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Cameron Park, California, Spojené státy, 95682
- Radiation Oncology Centers - Cameron Park
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Carmichael, California, Spojené státy, 95608
- Mercy Cancer Center at Mercy San Juan Medical Center
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Duarte, California, Spojené státy, 91010-3000
- City of Hope Comprehensive Cancer Center
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Fresno, California, Spojené státy, 93720
- California Cancer Center - Woodward Park Office
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La Jolla, California, Spojené státy, 92093-0658
- Rebecca and John Moores UCSD Cancer Center
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Roseville, California, Spojené státy, 95661
- Radiation Oncology Center - Roseville
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Sacramento, California, Spojené státy, 95815
- Radiological Associates of Sacramento Medical Group, Incorporated
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Sacramento, California, Spojené státy, 95819
- Mercy General Hospital
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San Diego, California, Spojené státy, 92161
- Veterans Affairs Medical Center - San Diego
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Vacaville, California, Spojené státy, 95687
- Solano Radiation Oncology Center
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Florida
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Boca Raton, Florida, Spojené státy, 33486
- Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus
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Gainesville, Florida, Spojené státy, 32610-0232
- University of Florida Shands Cancer Center
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Jacksonville, Florida, Spojené státy, 32207
- Baptist Cancer Institute - Jacksonville
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Miami, Florida, Spojené státy, 33176
- Baptist-South Miami Regional Cancer Program
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Orange Park, Florida, Spojené státy, 32073
- Integrated Community Oncology Network - Orange Park
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Panama City, Florida, Spojené státy, 32401
- Bay Medical
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Georgia
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Atlanta, Georgia, Spojené státy, 30309
- Piedmont Hospital
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Columbus, Georgia, Spojené státy, 31904
- John B. Amos Cancer Center
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Savannah, Georgia, Spojené státy, 31403-3089
- Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
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Illinois
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Springfield, Illinois, Spojené státy, 62702
- Cancer Institute at St. John's Hospital
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Indiana
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Anderson, Indiana, Spojené státy, 46016
- Saint John's Cancer Center at Saint John's Medical Center
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Goshen, Indiana, Spojené státy, 46526
- Center for Cancer Care at Goshen General Hospital
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Indianapolis, Indiana, Spojené státy, 46260
- St. Vincent Oncology Center
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Muncie, Indiana, Spojené státy, 47303-3499
- Cancer Center at Ball Memorial Hospital
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Kansas
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Overland Park, Kansas, Spojené státy, 66209
- Menorah Medical Center
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Overland Park, Kansas, Spojené státy, 66213
- Saint Luke's Hospital - South
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Shawnee Mission, Kansas, Spojené státy, 66204
- Shawnee Mission Medical Center
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Maryland
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Baltimore, Maryland, Spojené státy, 21201
- Greenebaum Cancer Center at University of Maryland Medical Center
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Massachusetts
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Boston, Massachusetts, Spojené státy, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, Spojené státy, 02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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Boston, Massachusetts, Spojené státy, 02118
- Boston University Cancer Research Center
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Boston, Massachusetts, Spojené státy, 02115
- Dana-Farber/Brigham and Women's Cancer Center
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Fall River, Massachusetts, Spojené státy, 02721
- Hudner Oncology Center at Saint Anne's Hospital - Fall River
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Minnesota
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Burnsville, Minnesota, Spojené státy, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, Spojené státy, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
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Edina, Minnesota, Spojené státy, 55435
- Fairview Southdale Hospital
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Fridley, Minnesota, Spojené státy, 55432
- Mercy and Unity Cancer Center at Unity Hospital
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Maplewood, Minnesota, Spojené státy, 55109
- Minnesota Oncology Hematology, PA - Maplewood
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Minneapolis, Minnesota, Spojené státy, 55407
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
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Robbinsdale, Minnesota, Spojené státy, 55422-2900
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
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Saint Louis Park, Minnesota, Spojené státy, 55416
- CCOP - Metro-Minnesota
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Saint Louis Park, Minnesota, Spojené státy, 55416
- Park Nicollet Cancer Center
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Saint Paul, Minnesota, Spojené státy, 55102
- United Hospital
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Shakopee, Minnesota, Spojené státy, 55379
- St. Francis Cancer Center at St. Francis Medical Center
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Waconia, Minnesota, Spojené státy, 55387
- Ridgeview Medical Center
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Woodbury, Minnesota, Spojené státy, 55125
- Minnesota Oncology Hematology, PA - Woodbury
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Mississippi
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Pascagoula, Mississippi, Spojené státy, 39581
- Regional Cancer Center at Singing River Hospital
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Missouri
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Cape Girardeau, Missouri, Spojené státy, 63703
- Cancer Institute of Cape Girardeau, LLC
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Kansas City, Missouri, Spojené státy, 64131
- CCOP - Kansas City
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Kansas City, Missouri, Spojené státy, 64116
- North Kansas City Hospital
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Kansas City, Missouri, Spojené státy, 64132
- Research Medical Center
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Kansas City, Missouri, Spojené státy, 64108
- Truman Medical Center - Hospital Hill
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Kansas City, Missouri, Spojené státy, 64111
- Saint Luke's Cancer Institute at Saint Luke's Hospital
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Kansas City, Missouri, Spojené státy, 64114
- St. Joseph Medical Center
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Kansas City, Missouri, Spojené státy, 64116
- Parvin Radiation Oncology
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Lee's Summit, Missouri, Spojené státy, 64086
- Saint Luke's East - Lee's Summit
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Liberty, Missouri, Spojené státy, 64068
- Liberty Hospital
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Saint Joseph, Missouri, Spojené státy, 64506
- Heartland Regional Medical Center
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Saint Louis, Missouri, Spojené státy, 63141
- Barnes-Jewish West County Hospital
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Saint Louis, Missouri, Spojené státy, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
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Saint Peters, Missouri, Spojené státy, 63376
- Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters
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Springfield, Missouri, Spojené státy, 65802
- CCOP - Cancer Research for the Ozarks
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Springfield, Missouri, Spojené státy, 65807
- Hulston Cancer Center at Cox Medical Center South
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Nebraska
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Omaha, Nebraska, Spojené státy, 68198
- Nebraska Medical Center
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Nevada
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Las Vegas, Nevada, Spojené státy, 89102
- University Medical Center of Southern Nevada
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Las Vegas, Nevada, Spojené státy, 89106
- CCOP - Nevada Cancer Research Foundation
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Reno, Nevada, Spojené státy, 89502
- Renown Institute for Cancer at Renown Regional Medical Center
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New Hampshire
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Keene, New Hampshire, Spojené státy, 03431
- Kingsbury Center for Cancer Care at Cheshire Medical Center
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Lebanon, New Hampshire, Spojené státy, 03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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New Jersey
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Long Branch, New Jersey, Spojené státy, 07740-6395
- Monmouth Medical Center
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Marlton, New Jersey, Spojené státy, 08053
- Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
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Toms River, New Jersey, Spojené státy, 08755
- J. Phillip Citta Regional Cancer Center at Community Medical Center
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New York
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Brooklyn, New York, Spojené státy, 11219
- Maimonides Cancer Center at Maimonides Medical Center
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Lake Success, New York, Spojené státy, 11042
- Monter Cancer Center of the North Shore-LIJ Health System
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Manhasset, New York, Spojené státy, 11030
- CCOP - North Shore University Hospital
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Manhasset, New York, Spojené státy, 11030
- Don Monti Comprehensive Cancer Center at North Shore University Hospital
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New Hyde Park, New York, Spojené státy, 11040
- Long Island Jewish Medical Center
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North Carolina
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Goldsboro, North Carolina, Spojené státy, 27534
- Wayne Radiation Oncology
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Goldsboro, North Carolina, Spojené státy, 27534
- Wayne Memorial Hospital, Incorporated
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Ohio
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Akron, Ohio, Spojené státy, 44309-2090
- Summa Center for Cancer Care at Akron City Hospital
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Barberton, Ohio, Spojené státy, 44203
- Barberton Citizens Hospital
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Cincinnati, Ohio, Spojené státy, 45267
- Charles M. Barrett Cancer Center at University Hospital
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Columbus, Ohio, Spojené státy, 43210-1240
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
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Salem, Ohio, Spojené státy, 44460
- Cancer Care Center, Incorporated
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West Chester, Ohio, Spojené státy, 45069
- Precision Radiotherapy at University Pointe
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Wooster, Ohio, Spojené státy, 44691
- Cancer Treatment Center
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Oklahoma
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Oklahoma City, Oklahoma, Spojené státy, 73104
- Oklahoma University Cancer Institute
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Oklahoma City, Oklahoma, Spojené státy, 73112
- Integris Oncology Services
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Pennsylvania
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Abington, Pennsylvania, Spojené státy, 19001
- Rosenfeld Cancer Center at Abington Memorial Hospital
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Bryn Mawr, Pennsylvania, Spojené státy, 19010
- Bryn Mawr Hospital
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Dunmore, Pennsylvania, Spojené státy, 18512
- Northeast Radiation Oncology Center
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East Stroudsburg, Pennsylvania, Spojené státy, 18301
- Dale and Frances Hughes Cancer Center at Pocono Medical Center
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Hershey, Pennsylvania, Spojené státy, 17033-0850
- Penn State Cancer Institute at Milton S. Hershey Medical Center
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Media, Pennsylvania, Spojené státy, 19063
- Riddle Memorial Hospital Cancer Center
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Milford, Pennsylvania, Spojené státy, 18337
- Upper Delaware Valley Cancer Center
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Paoli, Pennsylvania, Spojené státy, 19301-1792
- Cancer Center of Paoli Memorial Hospital
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Philadelphia, Pennsylvania, Spojené státy, 19107-5541
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
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Philadelphia, Pennsylvania, Spojené státy, 19114
- Frankford Hospital Cancer Center - Torresdale Campus
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Wynnewood, Pennsylvania, Spojené státy, 19096
- Lankenau Cancer Center at Lankenau Hospital
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Wynnewood, Pennsylvania, Spojené státy, 19096
- CCOP - Main Line Health
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Rhode Island
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Providence, Rhode Island, Spojené státy, 02903
- Rhode Island Hospital Comprehensive Cancer Center
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South Carolina
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Charleston, South Carolina, Spojené státy, 29425
- Hollings Cancer Center at Medical University of South Carolina
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Tennessee
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Kingsport, Tennessee, Spojené státy, 37662
- Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
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Utah
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American Fork, Utah, Spojené státy, 84003
- American Fork Hospital
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Cedar City, Utah, Spojené státy, 84720
- Sandra L. Maxwell Cancer Center
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Murray, Utah, Spojené státy, 84157
- Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
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Ogden, Utah, Spojené státy, 84403
- Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
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Provo, Utah, Spojené státy, 84604
- Utah Valley Regional Medical Center - Provo
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Saint George, Utah, Spojené státy, 84770
- Dixie Regional Medical Center - East Campus
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Salt Lake City, Utah, Spojené státy, 84103
- LDS Hospital
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Salt Lake City, Utah, Spojené státy, 84106
- Utah Cancer Specialists at UCS Cancer Center
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Vermont
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Saint Johnsbury, Vermont, Spojené státy, 05819
- Norris Cotton Cancer Center - North
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Virginia
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Charlottesville, Virginia, Spojené státy, 22908
- University of Virginia Cancer Center
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Norton, Virginia, Spojené státy, 24273
- Southwest Virginia Regional Cancer Center at Wellmonth Health
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Wisconsin
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Mequon, Wisconsin, Spojené státy, 53097
- Columbia Saint Mary's Hospital - Ozaukee
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Milwaukee, Wisconsin, Spojené státy, 53226
- Medical College of Wisconsin Cancer Center
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Milwaukee, Wisconsin, Spojené státy, 53211
- Columbia-Saint Mary's Cancer Care Center
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
DISEASE CHARACTERISTICS:
Pathologically confirmed diagnosis of adenocarcinoma of the rectum by biopsy technique that does not completely excise the lesion (e.g., fine needle aspiration, core needle biopsy)
- Located up to 12 cm from the anal verge with no extension of malignant disease into the anal canal
Clinically determined to be stage T3 or T4,N0-N2, and M0 tumor as determined by the following assessments:
- Colonoscopy and biopsy within 56 days prior to registration
- History/physical examination (including medication history screen for contraindications) within 56 days prior to registration
- Contrast-enhanced imaging of the abdomen and pelvis either by computed tomography(CT), MRI, or Positron-emission tomography(PET)-CT (whole body preferred) within 56 days prior to registration
- Chest x-ray (or CT) of the chest within within 56 days prior to registration to exclude distant metastases (except for patients who have had whole body PET-CT)
Transrectal ultrasound (TRUS) within 56 days prior to registration required to establish tumor stage
- TRUS not required if clinical exam, CT of the pelvis, and/or MRI demonstrates T4 lesion
- No synchronous primary colon carcinoma
- No evidence of distant metastases (M1)
PATIENT CHARACTERISTICS:
Inclusion criteria:
- Zubrod performance status 0-2
- Absolute neutrophil count (ANC) ≥ 1,800/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention to achieve hemoglobin ≥ 8.0 g/dL allowed)
- Aspartate aminotransferase (AST) < 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase < 2.5 times ULN
- Bilirubin ≤ 1.5 times ULN
- Creatinine clearance > 50 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior invasive malignancy except nonmelanoma skin cancer unless disease free for a minimum of 3 years
Exclusion criteria:
Severe, active comorbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within the past 12 months
- Transmural myocardial infarction within the past 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within the past 30 days
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- AIDS
- Evidence of uncontrolled seizures, central nervous system disorders, or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of oral drug intake
- Known, existing uncontrolled coagulopathy, unless clinically stable on anticoagulation therapy for ≥ 2 weeks
- Evidence of peripheral neuropathy ≥ grade 2
- Prior allergic reaction to oxaliplatin or capecitabine
- Lack of physical integrity of the gastrointestinal tract (i.e., severe Crohn disease that results in malabsorption; significant bowel resection that would make one concerned about the absorption of capecitabine) or malabsorption syndrome that would preclude feasibility of oral chemotherapy (i.e., capecitabine)
- Prior systemic chemotherapy for colorectal cancer (prior chemotherapy allowed provided it was for a cancer other than colorectal cancer)
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiotherapy fields
- Major surgery within 28 days of study enrollment(other than diverting colostomy without tumor resection)
- Participation in any investigational drug study within 28 days of study enrollment.
- Concurrent cimetidine, amifostine, and/or depot Sandostatin
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Jiný: IMRT + Chemotherapy , Resection, Postoperative Chemotherapy
Radiation therapy (intensity modulated radiation therapy [IMRT] + three dimensional conformal radiation therapy [3D-CRT]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
|
Ostatní jména:
1650 mg/m^2/day orally 5 days/week during radiotherapy.
All patients undergo surgery 4 to 8 weeks following the completion of radiation therapy.
The choice of procedure (abdominoperineal resection (APR), low anterior resection (LAR), or LAR/coloanal anastomosis) is at the discretion of the surgeon.
Pelvic intensity modulated radiation therapy (IMRT): 45 Gy in 25 fx Three dimensional conformal radiation therapy (3D-CRT) boost: 5.4 Gy in 3 fx to total dose of 50.4 Gy in 28 fx
Postoperative chemotherapy is administered to all patients who have a complete resection of rectal cancer with negative surgical margins and begins within 4-8 weeks following surgical resection, consisting of a total of 9 14-day cycles. Oxaliplatin 85 mg/m^2, IV over 2 hours, day 1. Leucovorin 400 mg/m^2, IV over 2 hours, day 1. 5-fluorouracil bolus 400 mg/m^2, IV push, day 1. 5-fluorouracil infusion 2400 mg/m^2, IV continuous infusion over 46 hours, day 1.
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
The Percentage of Patients Experiencing Treatment-related Gastrointestinal Adverse Events ≥ Grade 2 Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0, Occurring Preoperatively
Časové okno: From start of treatment to surgery or ≤ 90 days from the Start of Concurrent Treatment (for patients not undergoing surgery)
|
The percentage of patients experiencing preoperative treatment-related gastrointestinal adverse events ≥ grade 2. If patient did not receive surgery, then such adverse events <= 90 days from the start of concurrent treatment are included.
|
From start of treatment to surgery or ≤ 90 days from the Start of Concurrent Treatment (for patients not undergoing surgery)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Number of Patients in Protocol Adherence Categories for Intensity-modulated Radiotherapy (IMRT) Planning
Časové okno: Pretreatment
|
Real-time quality assurance was performed remotely by the study chair or the radiation oncology co-chair prior to initiation of treatment for the first 40 cases.
The final cases enrolled were reviewed within 3 months after accrual was completed.
Review included evaluation of clinical target volume (CTV) and planning target volume (PTV), Organs at Risk (OARs), and treatment plan dosimetry.
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Pretreatment
|
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Number of Patients With Pathologic Complete Response
Časové okno: At the time of surgery, which is 4-8 weeks after radiation therapy, approximately 9-13 weeks from treatment start.
|
Pathologic complete response is defined as no evidence of residual cancer histologically in the resection specimen.
|
At the time of surgery, which is 4-8 weeks after radiation therapy, approximately 9-13 weeks from treatment start.
|
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Percentage of Patients With Grade 3 or Higher Treatment-related Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v3.0
Časové okno: From study registration to end of follow-up. Maximum follow-up at time of analysis was 5.2 years.
|
Grade refers to the severity of the adverse event (AE).
The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Adverse events were compiled in four different time periods: 1) Preoperative: Preoperatively or, if no surgery, then ≤ 90 days from the Start of Concurrent Treatment; 2) Postoperative#1: Postoperatively and ≤ 30 days from the Date of Surgery; 3) Postoperative#2: Postoperatively and ≤ 90 days from the End of Postoperative Chemotherapy; 4) Overall: From start of concurrent treatment to end of follow-up;
|
From study registration to end of follow-up. Maximum follow-up at time of analysis was 5.2 years.
|
|
Local-regional Failure: 4-year Rate
Časové okno: From registration to four years
|
Local failure is defined as: (1) any recurrence or surgery to the primary site after a complete response (CR) reported at surgery or reported after the end of protocol treatment; or (2) persistence [failure at one day post study entry], absence of CR after protocol treatment was completed and patient lived at least 90 days from the end of treatment.
Regional failure is defined as: (1) any recurrence after a nodal CR reported at surgery or reported after the end of protocol treatment; or (2) persistence, absence of nodal CR after protocol treatment was completed and patient lived at least 90 days from the end of treatment.
Local-regional failure time is defined as time from registration to local or regional failure, last known follow-up (censored), or death (competing risk).
Local-regional failure rates are estimated by the cumulative incidence method.
|
From registration to four years
|
|
Distant Failure: 4-year Rate
Časové okno: From registration to four years
|
Distant failure is defined as the appearance of peritoneal seeding or distant metastases.
Time to distant failure is defined as time from registration to the date of distant failure, last known follow-up (censored), or death (competing risk).
Distant failure rates are estimated by the cumulative incidence method.
|
From registration to four years
|
|
Overall Survival: 4-year Rate
Časové okno: From registration to four years
|
Overall survival time is defined as time from registration to the date of death from any cause.
Overall survival rates are estimated by the Kaplan-Meier method.
Patients last known to be alive are censored at the date of last contact.
|
From registration to four years
|
|
Disease-free Survival: 4-year Rate
Časové okno: From registration to four years
|
Disease is defined as local-regional failure or distant failure.
Distant failure is defined as the appearance of peritoneal seeding or distant metastases.
Local-regional failure is defined as: (1) any recurrence or surgery to the primary site after a complete response (CR) / any recurrence after a nodal CR - reported at surgery or reported after the end of protocol treatment; or (2) persistence [failure at one day post study entry], absence of primary/nodal CR after protocol treatment was completed and patient lived at least 90 days from the end of treatment.
Disease-free survival time is defined as time from registration to the date of disease, death, or last known follow-up (censored).
Disease-free survival rates are estimated using the Kaplan-Meier method.
|
From registration to four years
|
|
Number of Patients Who Underwent Abdominoperineal Resection
Časové okno: Surgery occurred 4 to 8 weeks following the completion of radiation therapy, approximately 9-13 weeks from start of treatment.
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All patients were to undergo surgery 4 to 8 weeks following the completion of radiation therapy.
The choice of procedure (abdominoperineal resection (APR), low anterior resection (LAR), or LAR/coloanal anastomosis) was at the discretion of the surgeon.
If more than 28 patients received abdominoperineal resection, this would result in a conclusion of an excessive number of abdominoperineal resections.
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Surgery occurred 4 to 8 weeks following the completion of radiation therapy, approximately 9-13 weeks from start of treatment.
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Michael C. Garofalo, MD, University of Maryland Greenebaum Cancer Center
- Studijní židle: Adam C. Berger, MD, Sidney Kimmel Cancer Center at Thomas Jefferson University
- Studijní židle: Johanna Bendell, MD, Duke Cancer Institute
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. dubna 2008
Primární dokončení (Aktuální)
1. ledna 2010
Dokončení studie (Aktuální)
1. prosince 2016
Termíny zápisu do studia
První předloženo
9. února 2008
První předloženo, které splnilo kritéria kontroly kvality
9. února 2008
První zveřejněno (Odhad)
12. února 2008
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
25. září 2018
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
27. srpna 2018
Naposledy ověřeno
1. července 2018
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Nemoci trávicího systému
- Novotvary
- Novotvary podle místa
- Gastrointestinální novotvary
- Novotvary trávicího systému
- Gastrointestinální onemocnění
- Střevní nemoci
- Střevní novotvary
- Rektální onemocnění
- Kolorektální novotvary
- Rektální novotvary
- Fyziologické účinky léků
- Molekulární mechanismy farmakologického působení
- Antimetabolity, Antineoplastika
- Antimetabolity
- Antineoplastická činidla
- Imunosupresivní látky
- Imunologické faktory
- Ochranné prostředky
- Mikroživiny
- Vitamíny
- Protijedy
- Vitamín B komplex
- Fluorouracil
- Kapecitabin
- Oxaliplatina
- Leukovorin
Další identifikační čísla studie
- RTOG-0822
- CDR0000586277
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .