Combination Chemotherapy and Intensity-Modulated Radiation Therapy in Treating Patients Undergoing Surgery for Locally Advanced Rectal Cancer
27. august 2018 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
79
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Ontario
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London, Ontario, Canada, N6A 4L6
- London Regional Cancer Program at London Health Sciences Centre
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Alabama
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Mobile, Alabama, Forenede Stater, 36608
- Providence Cancer Center at Providence Hospital
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California
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Auburn, California, Forenede Stater, 95603
- Auburn Radiation Oncology
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Cameron Park, California, Forenede Stater, 95682
- Radiation Oncology Centers - Cameron Park
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Carmichael, California, Forenede Stater, 95608
- Mercy Cancer Center at Mercy San Juan Medical Center
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Duarte, California, Forenede Stater, 91010-3000
- City of Hope Comprehensive Cancer Center
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Fresno, California, Forenede Stater, 93720
- California Cancer Center - Woodward Park Office
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La Jolla, California, Forenede Stater, 92093-0658
- Rebecca and John Moores UCSD Cancer Center
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Roseville, California, Forenede Stater, 95661
- Radiation Oncology Center - Roseville
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Sacramento, California, Forenede Stater, 95815
- Radiological Associates of Sacramento Medical Group, Incorporated
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Sacramento, California, Forenede Stater, 95819
- Mercy General Hospital
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San Diego, California, Forenede Stater, 92161
- Veterans Affairs Medical Center - San Diego
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Vacaville, California, Forenede Stater, 95687
- Solano Radiation Oncology Center
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Florida
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Boca Raton, Florida, Forenede Stater, 33486
- Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus
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Gainesville, Florida, Forenede Stater, 32610-0232
- University of Florida Shands Cancer Center
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Jacksonville, Florida, Forenede Stater, 32207
- Baptist Cancer Institute - Jacksonville
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Miami, Florida, Forenede Stater, 33176
- Baptist-South Miami Regional Cancer Program
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Orange Park, Florida, Forenede Stater, 32073
- Integrated Community Oncology Network - Orange Park
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Panama City, Florida, Forenede Stater, 32401
- Bay Medical
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Georgia
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Atlanta, Georgia, Forenede Stater, 30309
- Piedmont Hospital
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Columbus, Georgia, Forenede Stater, 31904
- John B. Amos Cancer Center
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Savannah, Georgia, Forenede Stater, 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, Forenede Stater, 62702
- Cancer Institute at St. John's Hospital
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Indiana
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Anderson, Indiana, Forenede Stater, 46016
- Saint John's Cancer Center at Saint John's Medical Center
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Goshen, Indiana, Forenede Stater, 46526
- Center for Cancer Care at Goshen General Hospital
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Indianapolis, Indiana, Forenede Stater, 46260
- St. Vincent Oncology Center
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Muncie, Indiana, Forenede Stater, 47303-3499
- Cancer Center at Ball Memorial Hospital
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Kansas
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Overland Park, Kansas, Forenede Stater, 66209
- Menorah Medical Center
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Overland Park, Kansas, Forenede Stater, 66213
- Saint Luke's Hospital - South
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Shawnee Mission, Kansas, Forenede Stater, 66204
- Shawnee Mission Medical Center
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Maryland
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Baltimore, Maryland, Forenede Stater, 21201
- Greenebaum Cancer Center at University of Maryland Medical Center
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, Forenede Stater, 02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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Boston, Massachusetts, Forenede Stater, 02118
- Boston University Cancer Research Center
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Boston, Massachusetts, Forenede Stater, 02115
- Dana-Farber/Brigham and Women's Cancer Center
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Fall River, Massachusetts, Forenede Stater, 02721
- Hudner Oncology Center at Saint Anne's Hospital - Fall River
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Minnesota
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Burnsville, Minnesota, Forenede Stater, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, Forenede Stater, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
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Edina, Minnesota, Forenede Stater, 55435
- Fairview Southdale Hospital
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Fridley, Minnesota, Forenede Stater, 55432
- Mercy and Unity Cancer Center at Unity Hospital
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Maplewood, Minnesota, Forenede Stater, 55109
- Minnesota Oncology Hematology, PA - Maplewood
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Minneapolis, Minnesota, Forenede Stater, 55407
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
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Robbinsdale, Minnesota, Forenede Stater, 55422-2900
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
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Saint Louis Park, Minnesota, Forenede Stater, 55416
- CCOP - Metro-Minnesota
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Saint Louis Park, Minnesota, Forenede Stater, 55416
- Park Nicollet Cancer Center
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Saint Paul, Minnesota, Forenede Stater, 55102
- United Hospital
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Shakopee, Minnesota, Forenede Stater, 55379
- St. Francis Cancer Center at St. Francis Medical Center
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Waconia, Minnesota, Forenede Stater, 55387
- Ridgeview Medical Center
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Woodbury, Minnesota, Forenede Stater, 55125
- Minnesota Oncology Hematology, PA - Woodbury
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Mississippi
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Pascagoula, Mississippi, Forenede Stater, 39581
- Regional Cancer Center at Singing River Hospital
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Missouri
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Cape Girardeau, Missouri, Forenede Stater, 63703
- Cancer Institute of Cape Girardeau, LLC
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Kansas City, Missouri, Forenede Stater, 64131
- CCOP - Kansas City
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Kansas City, Missouri, Forenede Stater, 64116
- North Kansas City Hospital
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Kansas City, Missouri, Forenede Stater, 64132
- Research Medical Center
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Kansas City, Missouri, Forenede Stater, 64108
- Truman Medical Center - Hospital Hill
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Kansas City, Missouri, Forenede Stater, 64111
- Saint Luke's Cancer Institute at Saint Luke's Hospital
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Kansas City, Missouri, Forenede Stater, 64114
- St. Joseph Medical Center
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Kansas City, Missouri, Forenede Stater, 64116
- Parvin Radiation Oncology
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Lee's Summit, Missouri, Forenede Stater, 64086
- Saint Luke's East - Lee's Summit
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Liberty, Missouri, Forenede Stater, 64068
- Liberty Hospital
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Saint Joseph, Missouri, Forenede Stater, 64506
- Heartland Regional Medical Center
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Saint Louis, Missouri, Forenede Stater, 63141
- Barnes-Jewish West County Hospital
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Saint Louis, Missouri, Forenede Stater, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
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Saint Peters, Missouri, Forenede Stater, 63376
- Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters
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Springfield, Missouri, Forenede Stater, 65802
- CCOP - Cancer Research for the Ozarks
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Springfield, Missouri, Forenede Stater, 65807
- Hulston Cancer Center at Cox Medical Center South
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68198
- Nebraska Medical Center
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89102
- University Medical Center of Southern Nevada
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Las Vegas, Nevada, Forenede Stater, 89106
- CCOP - Nevada Cancer Research Foundation
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Reno, Nevada, Forenede Stater, 89502
- Renown Institute for Cancer at Renown Regional Medical Center
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New Hampshire
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Keene, New Hampshire, Forenede Stater, 03431
- Kingsbury Center for Cancer Care at Cheshire Medical Center
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Lebanon, New Hampshire, Forenede Stater, 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, Forenede Stater, 07740-6395
- Monmouth Medical Center
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Marlton, New Jersey, Forenede Stater, 08053
- Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
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Toms River, New Jersey, Forenede Stater, 08755
- J. Phillip Citta Regional Cancer Center at Community Medical Center
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New York
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Brooklyn, New York, Forenede Stater, 11219
- Maimonides Cancer Center at Maimonides Medical Center
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Lake Success, New York, Forenede Stater, 11042
- Monter Cancer Center of the North Shore-LIJ Health System
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Manhasset, New York, Forenede Stater, 11030
- CCOP - North Shore University Hospital
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Manhasset, New York, Forenede Stater, 11030
- Don Monti Comprehensive Cancer Center at North Shore University Hospital
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New Hyde Park, New York, Forenede Stater, 11040
- Long Island Jewish Medical Center
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North Carolina
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Goldsboro, North Carolina, Forenede Stater, 27534
- Wayne Radiation Oncology
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Goldsboro, North Carolina, Forenede Stater, 27534
- Wayne Memorial Hospital, Incorporated
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Ohio
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Akron, Ohio, Forenede Stater, 44309-2090
- Summa Center for Cancer Care at Akron City Hospital
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Barberton, Ohio, Forenede Stater, 44203
- Barberton Citizens Hospital
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Cincinnati, Ohio, Forenede Stater, 45267
- Charles M. Barrett Cancer Center at University Hospital
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Columbus, Ohio, Forenede Stater, 43210-1240
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
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Salem, Ohio, Forenede Stater, 44460
- Cancer Care Center, Incorporated
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West Chester, Ohio, Forenede Stater, 45069
- Precision Radiotherapy at University Pointe
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Wooster, Ohio, Forenede Stater, 44691
- Cancer Treatment Center
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73104
- Oklahoma University Cancer Institute
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Oklahoma City, Oklahoma, Forenede Stater, 73112
- Integris Oncology Services
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Pennsylvania
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Abington, Pennsylvania, Forenede Stater, 19001
- Rosenfeld Cancer Center at Abington Memorial Hospital
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Bryn Mawr, Pennsylvania, Forenede Stater, 19010
- Bryn Mawr Hospital
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Dunmore, Pennsylvania, Forenede Stater, 18512
- Northeast Radiation Oncology Center
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East Stroudsburg, Pennsylvania, Forenede Stater, 18301
- Dale and Frances Hughes Cancer Center at Pocono Medical Center
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Hershey, Pennsylvania, Forenede Stater, 17033-0850
- Penn State Cancer Institute at Milton S. Hershey Medical Center
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Media, Pennsylvania, Forenede Stater, 19063
- Riddle Memorial Hospital Cancer Center
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Milford, Pennsylvania, Forenede Stater, 18337
- Upper Delaware Valley Cancer Center
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Paoli, Pennsylvania, Forenede Stater, 19301-1792
- Cancer Center of Paoli Memorial Hospital
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Philadelphia, Pennsylvania, Forenede Stater, 19107-5541
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
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Philadelphia, Pennsylvania, Forenede Stater, 19114
- Frankford Hospital Cancer Center - Torresdale Campus
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Wynnewood, Pennsylvania, Forenede Stater, 19096
- Lankenau Cancer Center at Lankenau Hospital
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Wynnewood, Pennsylvania, Forenede Stater, 19096
- CCOP - Main Line Health
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Rhode Island
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Providence, Rhode Island, Forenede Stater, 02903
- Rhode Island Hospital Comprehensive Cancer Center
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29425
- Hollings Cancer Center at Medical University of South Carolina
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Tennessee
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Kingsport, Tennessee, Forenede Stater, 37662
- Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
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Utah
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American Fork, Utah, Forenede Stater, 84003
- American Fork Hospital
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Cedar City, Utah, Forenede Stater, 84720
- Sandra L. Maxwell Cancer Center
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Murray, Utah, Forenede Stater, 84157
- Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
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Ogden, Utah, Forenede Stater, 84403
- Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
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Provo, Utah, Forenede Stater, 84604
- Utah Valley Regional Medical Center - Provo
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Saint George, Utah, Forenede Stater, 84770
- Dixie Regional Medical Center - East Campus
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Salt Lake City, Utah, Forenede Stater, 84103
- LDS Hospital
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Salt Lake City, Utah, Forenede Stater, 84106
- Utah Cancer Specialists at UCS Cancer Center
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Vermont
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Saint Johnsbury, Vermont, Forenede Stater, 05819
- Norris Cotton Cancer Center - North
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Virginia
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Charlottesville, Virginia, Forenede Stater, 22908
- University of Virginia Cancer Center
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Norton, Virginia, Forenede Stater, 24273
- Southwest Virginia Regional Cancer Center at Wellmonth Health
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Wisconsin
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Mequon, Wisconsin, Forenede Stater, 53097
- Columbia Saint Mary's Hospital - Ozaukee
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Milwaukee, Wisconsin, Forenede Stater, 53226
- Medical College of Wisconsin Cancer Center
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Milwaukee, Wisconsin, Forenede Stater, 53211
- Columbia-Saint Mary's Cancer Care Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Andet: 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)
|
Andre navne:
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.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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
Tidsramme: From start of treatment to surgery or ≤ 90 days from the Start of Concurrent Treatment (for patients not undergoing surgery)
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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.
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From start of treatment to surgery or ≤ 90 days from the Start of Concurrent Treatment (for patients not undergoing surgery)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Patients in Protocol Adherence Categories for Intensity-modulated Radiotherapy (IMRT) Planning
Tidsramme: Pretreatment
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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
Tidsramme: At the time of surgery, which is 4-8 weeks after radiation therapy, approximately 9-13 weeks from treatment start.
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Pathologic complete response is defined as no evidence of residual cancer histologically in the resection specimen.
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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
Tidsramme: From study registration to end of follow-up. Maximum follow-up at time of analysis was 5.2 years.
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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;
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From study registration to end of follow-up. Maximum follow-up at time of analysis was 5.2 years.
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Local-regional Failure: 4-year Rate
Tidsramme: From registration to four years
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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.
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From registration to four years
|
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Distant Failure: 4-year Rate
Tidsramme: 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.
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From registration to four years
|
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Overall Survival: 4-year Rate
Tidsramme: 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.
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From registration to four years
|
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Disease-free Survival: 4-year Rate
Tidsramme: 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
|
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Number of Patients Who Underwent Abdominoperineal Resection
Tidsramme: Surgery occurred 4 to 8 weeks following the completion of radiation therapy, approximately 9-13 weeks from start of treatment.
|
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.
|
Surgery occurred 4 to 8 weeks following the completion of radiation therapy, approximately 9-13 weeks from start of treatment.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Michael C. Garofalo, MD, University of Maryland Greenebaum Cancer Center
- Studiestol: Adam C. Berger, MD, Sidney Kimmel Cancer Center at Thomas Jefferson University
- Studiestol: Johanna Bendell, MD, Duke Cancer Institute
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. april 2008
Primær færdiggørelse (Faktiske)
1. januar 2010
Studieafslutning (Faktiske)
1. december 2016
Datoer for studieregistrering
Først indsendt
9. februar 2008
Først indsendt, der opfyldte QC-kriterier
9. februar 2008
Først opslået (Skøn)
12. februar 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
25. september 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. august 2018
Sidst verificeret
1. juli 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Neoplasmer
- Neoplasmer efter sted
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Gastrointestinale sygdomme
- Tarmsygdomme
- Intestinale neoplasmer
- Endetarmssygdomme
- Kolorektale neoplasmer
- Rektale neoplasmer
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Beskyttelsesagenter
- Mikronæringsstoffer
- Vitaminer
- Modgift
- Vitamin B kompleks
- Fluorouracil
- Capecitabin
- Oxaliplatin
- Leucovorin
Andre undersøgelses-id-numre
- RTOG-0822
- CDR0000586277
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