Combination Chemotherapy and Intensity-Modulated Radiation Therapy in Treating Patients Undergoing Surgery for Locally Advanced Rectal Cancer
27. August 2018 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
79
Phase
- Phase 2
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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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, Vereinigte Staaten, 36608
- Providence Cancer Center at Providence Hospital
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California
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Auburn, California, Vereinigte Staaten, 95603
- Auburn Radiation Oncology
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Cameron Park, California, Vereinigte Staaten, 95682
- Radiation Oncology Centers - Cameron Park
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Carmichael, California, Vereinigte Staaten, 95608
- Mercy Cancer Center at Mercy San Juan Medical Center
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Duarte, California, Vereinigte Staaten, 91010-3000
- City of Hope Comprehensive Cancer Center
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Fresno, California, Vereinigte Staaten, 93720
- California Cancer Center - Woodward Park Office
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La Jolla, California, Vereinigte Staaten, 92093-0658
- Rebecca and John Moores UCSD Cancer Center
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Roseville, California, Vereinigte Staaten, 95661
- Radiation Oncology Center - Roseville
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Sacramento, California, Vereinigte Staaten, 95815
- Radiological Associates of Sacramento Medical Group, Incorporated
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Sacramento, California, Vereinigte Staaten, 95819
- Mercy General Hospital
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San Diego, California, Vereinigte Staaten, 92161
- Veterans Affairs Medical Center - San Diego
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Vacaville, California, Vereinigte Staaten, 95687
- Solano Radiation Oncology Center
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Florida
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Boca Raton, Florida, Vereinigte Staaten, 33486
- Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus
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Gainesville, Florida, Vereinigte Staaten, 32610-0232
- University of Florida Shands Cancer Center
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Jacksonville, Florida, Vereinigte Staaten, 32207
- Baptist Cancer Institute - Jacksonville
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Miami, Florida, Vereinigte Staaten, 33176
- Baptist-South Miami Regional Cancer Program
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Orange Park, Florida, Vereinigte Staaten, 32073
- Integrated Community Oncology Network - Orange Park
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Panama City, Florida, Vereinigte Staaten, 32401
- Bay Medical
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Georgia
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Atlanta, Georgia, Vereinigte Staaten, 30309
- Piedmont Hospital
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Columbus, Georgia, Vereinigte Staaten, 31904
- John B. Amos Cancer Center
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Savannah, Georgia, Vereinigte Staaten, 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, Vereinigte Staaten, 62702
- Cancer Institute at St. John's Hospital
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Indiana
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Anderson, Indiana, Vereinigte Staaten, 46016
- Saint John's Cancer Center at Saint John's Medical Center
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Goshen, Indiana, Vereinigte Staaten, 46526
- Center for Cancer Care at Goshen General Hospital
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Indianapolis, Indiana, Vereinigte Staaten, 46260
- St. Vincent Oncology Center
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Muncie, Indiana, Vereinigte Staaten, 47303-3499
- Cancer Center at Ball Memorial Hospital
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Kansas
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Overland Park, Kansas, Vereinigte Staaten, 66209
- Menorah Medical Center
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Overland Park, Kansas, Vereinigte Staaten, 66213
- Saint Luke's Hospital - South
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Shawnee Mission, Kansas, Vereinigte Staaten, 66204
- Shawnee Mission Medical Center
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Maryland
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Baltimore, Maryland, Vereinigte Staaten, 21201
- Greenebaum Cancer Center at University of Maryland Medical Center
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Massachusetts
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Boston, Massachusetts, Vereinigte Staaten, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, Vereinigte Staaten, 02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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Boston, Massachusetts, Vereinigte Staaten, 02118
- Boston University Cancer Research Center
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Boston, Massachusetts, Vereinigte Staaten, 02115
- Dana-Farber/Brigham and Women's Cancer Center
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Fall River, Massachusetts, Vereinigte Staaten, 02721
- Hudner Oncology Center at Saint Anne's Hospital - Fall River
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Minnesota
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Burnsville, Minnesota, Vereinigte Staaten, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, Vereinigte Staaten, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
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Edina, Minnesota, Vereinigte Staaten, 55435
- Fairview Southdale Hospital
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Fridley, Minnesota, Vereinigte Staaten, 55432
- Mercy and Unity Cancer Center at Unity Hospital
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Maplewood, Minnesota, Vereinigte Staaten, 55109
- Minnesota Oncology Hematology, PA - Maplewood
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Minneapolis, Minnesota, Vereinigte Staaten, 55407
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
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Robbinsdale, Minnesota, Vereinigte Staaten, 55422-2900
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
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Saint Louis Park, Minnesota, Vereinigte Staaten, 55416
- CCOP - Metro-Minnesota
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Saint Louis Park, Minnesota, Vereinigte Staaten, 55416
- Park Nicollet Cancer Center
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Saint Paul, Minnesota, Vereinigte Staaten, 55102
- United Hospital
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Shakopee, Minnesota, Vereinigte Staaten, 55379
- St. Francis Cancer Center at St. Francis Medical Center
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Waconia, Minnesota, Vereinigte Staaten, 55387
- Ridgeview Medical Center
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Woodbury, Minnesota, Vereinigte Staaten, 55125
- Minnesota Oncology Hematology, PA - Woodbury
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Mississippi
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Pascagoula, Mississippi, Vereinigte Staaten, 39581
- Regional Cancer Center at Singing River Hospital
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Missouri
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Cape Girardeau, Missouri, Vereinigte Staaten, 63703
- Cancer Institute of Cape Girardeau, LLC
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Kansas City, Missouri, Vereinigte Staaten, 64131
- CCOP - Kansas City
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Kansas City, Missouri, Vereinigte Staaten, 64116
- North Kansas City Hospital
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Kansas City, Missouri, Vereinigte Staaten, 64132
- Research Medical Center
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Kansas City, Missouri, Vereinigte Staaten, 64108
- Truman Medical Center - Hospital Hill
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Kansas City, Missouri, Vereinigte Staaten, 64111
- Saint Luke's Cancer Institute at Saint Luke's Hospital
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Kansas City, Missouri, Vereinigte Staaten, 64114
- St. Joseph Medical Center
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Kansas City, Missouri, Vereinigte Staaten, 64116
- Parvin Radiation Oncology
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Lee's Summit, Missouri, Vereinigte Staaten, 64086
- Saint Luke's East - Lee's Summit
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Liberty, Missouri, Vereinigte Staaten, 64068
- Liberty Hospital
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Saint Joseph, Missouri, Vereinigte Staaten, 64506
- Heartland Regional Medical Center
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Saint Louis, Missouri, Vereinigte Staaten, 63141
- Barnes-Jewish West County Hospital
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Saint Louis, Missouri, Vereinigte Staaten, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
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Saint Peters, Missouri, Vereinigte Staaten, 63376
- Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters
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Springfield, Missouri, Vereinigte Staaten, 65802
- CCOP - Cancer Research for the Ozarks
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Springfield, Missouri, Vereinigte Staaten, 65807
- Hulston Cancer Center at Cox Medical Center South
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Nebraska
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Omaha, Nebraska, Vereinigte Staaten, 68198
- Nebraska Medical Center
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Nevada
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Las Vegas, Nevada, Vereinigte Staaten, 89102
- University Medical Center of Southern Nevada
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Las Vegas, Nevada, Vereinigte Staaten, 89106
- CCOP - Nevada Cancer Research Foundation
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Reno, Nevada, Vereinigte Staaten, 89502
- Renown Institute for Cancer at Renown Regional Medical Center
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New Hampshire
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Keene, New Hampshire, Vereinigte Staaten, 03431
- Kingsbury Center for Cancer Care at Cheshire Medical Center
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Lebanon, New Hampshire, Vereinigte Staaten, 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, Vereinigte Staaten, 07740-6395
- Monmouth Medical Center
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Marlton, New Jersey, Vereinigte Staaten, 08053
- Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
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Toms River, New Jersey, Vereinigte Staaten, 08755
- J. Phillip Citta Regional Cancer Center at Community Medical Center
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New York
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Brooklyn, New York, Vereinigte Staaten, 11219
- Maimonides Cancer Center at Maimonides Medical Center
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Lake Success, New York, Vereinigte Staaten, 11042
- Monter Cancer Center of the North Shore-LIJ Health System
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Manhasset, New York, Vereinigte Staaten, 11030
- CCOP - North Shore University Hospital
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Manhasset, New York, Vereinigte Staaten, 11030
- Don Monti Comprehensive Cancer Center at North Shore University Hospital
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New Hyde Park, New York, Vereinigte Staaten, 11040
- Long Island Jewish Medical Center
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North Carolina
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Goldsboro, North Carolina, Vereinigte Staaten, 27534
- Wayne Radiation Oncology
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Goldsboro, North Carolina, Vereinigte Staaten, 27534
- Wayne Memorial Hospital, Incorporated
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Ohio
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Akron, Ohio, Vereinigte Staaten, 44309-2090
- Summa Center for Cancer Care at Akron City Hospital
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Barberton, Ohio, Vereinigte Staaten, 44203
- Barberton Citizens Hospital
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Cincinnati, Ohio, Vereinigte Staaten, 45267
- Charles M. Barrett Cancer Center at University Hospital
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Columbus, Ohio, Vereinigte Staaten, 43210-1240
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
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Salem, Ohio, Vereinigte Staaten, 44460
- Cancer Care Center, Incorporated
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West Chester, Ohio, Vereinigte Staaten, 45069
- Precision Radiotherapy at University Pointe
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Wooster, Ohio, Vereinigte Staaten, 44691
- Cancer Treatment Center
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Oklahoma
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Oklahoma City, Oklahoma, Vereinigte Staaten, 73104
- Oklahoma University Cancer Institute
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Oklahoma City, Oklahoma, Vereinigte Staaten, 73112
- Integris Oncology Services
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Pennsylvania
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Abington, Pennsylvania, Vereinigte Staaten, 19001
- Rosenfeld Cancer Center at Abington Memorial Hospital
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Bryn Mawr, Pennsylvania, Vereinigte Staaten, 19010
- Bryn Mawr Hospital
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Dunmore, Pennsylvania, Vereinigte Staaten, 18512
- Northeast Radiation Oncology Center
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East Stroudsburg, Pennsylvania, Vereinigte Staaten, 18301
- Dale and Frances Hughes Cancer Center at Pocono Medical Center
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Hershey, Pennsylvania, Vereinigte Staaten, 17033-0850
- Penn State Cancer Institute at Milton S. Hershey Medical Center
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Media, Pennsylvania, Vereinigte Staaten, 19063
- Riddle Memorial Hospital Cancer Center
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Milford, Pennsylvania, Vereinigte Staaten, 18337
- Upper Delaware Valley Cancer Center
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Paoli, Pennsylvania, Vereinigte Staaten, 19301-1792
- Cancer Center of Paoli Memorial Hospital
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Philadelphia, Pennsylvania, Vereinigte Staaten, 19107-5541
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
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Philadelphia, Pennsylvania, Vereinigte Staaten, 19114
- Frankford Hospital Cancer Center - Torresdale Campus
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Wynnewood, Pennsylvania, Vereinigte Staaten, 19096
- Lankenau Cancer Center at Lankenau Hospital
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Wynnewood, Pennsylvania, Vereinigte Staaten, 19096
- CCOP - Main Line Health
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Rhode Island
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Providence, Rhode Island, Vereinigte Staaten, 02903
- Rhode Island Hospital Comprehensive Cancer Center
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South Carolina
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Charleston, South Carolina, Vereinigte Staaten, 29425
- Hollings Cancer Center at Medical University of South Carolina
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Tennessee
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Kingsport, Tennessee, Vereinigte Staaten, 37662
- Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
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Utah
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American Fork, Utah, Vereinigte Staaten, 84003
- American Fork Hospital
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Cedar City, Utah, Vereinigte Staaten, 84720
- Sandra L. Maxwell Cancer Center
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Murray, Utah, Vereinigte Staaten, 84157
- Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
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Ogden, Utah, Vereinigte Staaten, 84403
- Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
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Provo, Utah, Vereinigte Staaten, 84604
- Utah Valley Regional Medical Center - Provo
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Saint George, Utah, Vereinigte Staaten, 84770
- Dixie Regional Medical Center - East Campus
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Salt Lake City, Utah, Vereinigte Staaten, 84103
- LDS Hospital
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Salt Lake City, Utah, Vereinigte Staaten, 84106
- Utah Cancer Specialists at UCS Cancer Center
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Vermont
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Saint Johnsbury, Vermont, Vereinigte Staaten, 05819
- Norris Cotton Cancer Center - North
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Virginia
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Charlottesville, Virginia, Vereinigte Staaten, 22908
- University of Virginia Cancer Center
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Norton, Virginia, Vereinigte Staaten, 24273
- Southwest Virginia Regional Cancer Center at Wellmonth Health
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Wisconsin
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Mequon, Wisconsin, Vereinigte Staaten, 53097
- Columbia Saint Mary's Hospital - Ozaukee
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Milwaukee, Wisconsin, Vereinigte Staaten, 53226
- Medical College of Wisconsin Cancer Center
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Milwaukee, Wisconsin, Vereinigte Staaten, 53211
- Columbia-Saint Mary's Cancer Care Center
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Sonstiges: 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)
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Andere Namen:
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.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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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
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Number of Patients in Protocol Adherence Categories for Intensity-modulated Radiotherapy (IMRT) Planning
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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;
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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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
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From registration to four years
|
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Number of Patients Who Underwent Abdominoperineal Resection
Zeitfenster: 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.
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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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Michael C. Garofalo, MD, University of Maryland Greenebaum Cancer Center
- Studienstuhl: Adam C. Berger, MD, Sidney Kimmel Cancer Center at Thomas Jefferson University
- Studienstuhl: Johanna Bendell, MD, Duke Cancer Institute
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. April 2008
Primärer Abschluss (Tatsächlich)
1. Januar 2010
Studienabschluss (Tatsächlich)
1. Dezember 2016
Studienanmeldedaten
Zuerst eingereicht
9. Februar 2008
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
9. Februar 2008
Zuerst gepostet (Schätzen)
12. Februar 2008
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
25. September 2018
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
27. August 2018
Zuletzt verifiziert
1. Juli 2018
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Verdauungssystems
- Neubildungen
- Neubildungen nach Standort
- Gastrointestinale Neubildungen
- Neoplasmen des Verdauungssystems
- Magen-Darm-Erkrankungen
- Darmerkrankungen
- Darmtumoren
- Rektale Erkrankungen
- Kolorektale Neubildungen
- Rektale Neoplasien
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Antimetaboliten, antineoplastisch
- Antimetaboliten
- Antineoplastische Mittel
- Immunsuppressive Mittel
- Immunologische Faktoren
- Schutzmittel
- Mikronährstoffe
- Vitamine
- Gegenmittel
- Vitamin B-Komplex
- Fluorouracil
- Capecitabin
- Oxaliplatin
- Leucovorin
Andere Studien-ID-Nummern
- RTOG-0822
- CDR0000586277
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