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
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.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The Percentage of Patients Experiencing Treatment-related Gastrointestinal Adverse Events ≥ Grade 2 Per National Cancer Institute (NCI) Common Terminology Critereia for Adverse Events (CTCAE) v. 3.0, Occurring Preoperatively
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)
Yes
Michael C. Garofalo, MD
Principal Investigator
University of Maryland Greenebaum Cancer Center
United States: Federal Government
RTOG-0822
NCT00613080
April 2008
Name | Location |
---|---|
CCOP - Kansas City | Kansas City, Missouri 64131 |
CCOP - North Shore University Hospital | Manhasset, New York 11030 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
Fairview Southdale Hospital | Edina, Minnesota 55435 |
Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota 55432 |
Minnesota Oncology Hematology, PA - Maplewood | Maplewood, Minnesota 55109 |
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis, Minnesota 55407 |
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale, Minnesota 55422-2900 |
St. Francis Cancer Center at St. Francis Medical Center | Shakopee, Minnesota 55379 |
Park Nicollet Cancer Center | St. Louis Park, Minnesota 55416 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
Minnesota Oncology Hematology, PA - Woodbury | Woodbury, Minnesota 55125 |
Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
LDS Hospital | Salt Lake City, Utah 84143 |
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
Utah Valley Regional Medical Center - Provo | Provo, Utah 84604 |
Monmouth Medical Center | Long Branch, New Jersey 07740-6395 |
Rebecca and John Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
Veterans Affairs Medical Center - San Diego | San Diego, California 92161 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
Long Island Jewish Medical Center | New Hyde Park, New York 11040 |
University of Florida Shands Cancer Center | Gainesville, Florida 32610-0232 |
Baptist-South Miami Regional Cancer Program | Miami, Florida 33176 |
Rhode Island Hospital Comprehensive Cancer Center | Providence, Rhode Island 02903 |
Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
Baptist Cancer Institute - Jacksonville | Jacksonville, Florida 32207 |
Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
American Fork Hospital | American Fork, Utah 84003 |
Utah Cancer Specialists at UCS Cancer Center | Salt Lake City, Utah 84106 |
Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland 21201 |
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah, Georgia 31403-3089 |
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
CCOP - Nevada Cancer Research Foundation | Las Vegas, Nevada 89109-2306 |
Maimonides Cancer Center at Maimonides Medical Center | Brooklyn, New York 11219 |
Don Monti Comprehensive Cancer Center at North Shore University Hospital | Manhasset, New York 11030 |
Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
University of Virginia Cancer Center | Charlottesville, Virginia 22908 |
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | Marlton, New Jersey 08053 |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus, Ohio 43210-1240 |
Rosenfeld Cancer Center at Abington Memorial Hospital | Abington, Pennsylvania 19001 |
University Medical Center of Southern Nevada | Las Vegas, Nevada 89102 |
Piedmont Hospital | Atlanta, Georgia 30309 |
Kingsbury Center for Cancer Care at Cheshire Medical Center | Keene, New Hampshire 03431 |
Wayne Radiation Oncology | Goldsboro, North Carolina 27534 |
Bryn Mawr Hospital | Bryn Mawr, Pennsylvania 19010 |
Lankenau Cancer Center at Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center | Kingsport, Tennessee 37662 |
Dixie Regional Medical Center - East Campus | Saint George, Utah 84770 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
California Cancer Center - Woodward Park Office | Fresno, California 93720 |
Cancer Center at Ball Memorial Hospital | Muncie, Indiana 47303 |
Regional Cancer Center at Singing River Hospital | Pascagoula, Mississippi 39581 |
Cancer Treatment Center | Wooster, Ohio 44691 |
John B. Amos Cancer Center | Columbus, Georgia 31904 |
Menorah Medical Center | Overland Park, Kansas 66209 |
Saint Luke's Hospital - South | Overland Park, Kansas 66213 |
Shawnee Mission Medical Center | Shawnee Mission, Kansas 66204 |
Truman Medical Center - Hospital Hill | Kansas City, Missouri 64108 |
St. Joseph Medical Center | Kansas City, Missouri 64114 |
North Kansas City Hospital | Kansas City, Missouri 64116 |
Saint Luke's Cancer Institute at Saint Luke's Hospital | Kansas City, Missouri 64111 |
Research Medical Center | Kansas City, Missouri 64132 |
Saint Luke's East - Lee's Summit | Lee's Summit, Missouri 64086 |
Liberty Hospital | Liberty, Missouri 64068 |
Heartland Regional Medical Center | Saint Joseph, Missouri 64506 |
Monter Cancer Center of the North Shore-LIJ Health System | Lake Success, New York 11042 |
Summa Center for Cancer Care at Akron City Hospital | Akron, Ohio 44309-2090 |
Barberton Citizens Hospital | Barberton, Ohio 44203 |
Sandra L. Maxwell Cancer Center | Cedar City, Utah 84720 |
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center | Murray, Utah 84157 |
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center | Ogden, Utah 84403 |
Southwest Virginia Regional Cancer Center at Wellmonth Health | Norton, Virginia 24273 |
Radiological Associates of Sacramento Medical Group, Incorporated | Sacramento, California 95815 |
Dana-Farber/Brigham and Women's Cancer Center | Boston, Massachusetts 02115 |
Cancer Institute at St. John's Hospital | Springfield, Illinois 62701 |
Solano Radiation Oncology Center | Vacaville, California 95687 |
Boston University Cancer Research Center | Boston, Massachusetts 02118 |
Parvin Radiation Oncology | Kansas City, Missouri 64116 |
Mercy General Hospital | Sacramento, California 95819 |
Providence Cancer Center at Providence Hospital | Mobile, Alabama 36608 |
Riddle Memorial Hospital Cancer Center | Media, Pennsylvania 19063 |
Cancer Center of Paoli Memorial Hospital | Paoli, Pennsylvania 19301-1792 |
CCOP - Main Line Health | Wynnewood, Pennsylvania 19096 |
Dale and Frances Hughes Cancer Center at Pocono Medical Center | East Stroudsburg, Pennsylvania 18301 |
Cancer Care Center, Incorporated | Salem, Ohio 44460 |
Center for Cancer Care at Goshen General Hospital | Goshen, Indiana 46526 |
Bay Medical | Panama City, Florida 32401 |
Cancer Institute of Cape Girardeau, LLC | Cape Girardeau, Missouri 63703 |
J. Phillip Citta Regional Cancer Center at Community Medical Center | Toms River, New Jersey 08755 |
Precision Radiotherapy at University Pointe | West Chester, Ohio 45069 |
Integrated Community Oncology Network - Orange Park | Orange Park, Florida 32073 |
Hudner Oncology Center at Saint Anne's Hospital - Fall River | Fall River, Massachusetts 02721 |
Columbia Saint Mary's Hospital - Ozaukee | Mequon, Wisconsin 53097 |
Columbia-Saint Mary's Cancer Care Center | Milwaukee, Wisconsin 53211 |
Frankford Hospital Cancer Center - Torresdale Campus | Philadelphia, Pennsylvania 19114 |
Integris Oncology Services | Oklahoma City, Oklahoma 73112 |
Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus | Boca Raton, Florida 33486 |
Auburn Radiation Oncology | Auburn, California 95603 |
Radiation Oncology Centers - Cameron Park | Cameron Park, California 95682 |
Radiation Oncology Center - Roseville | Roseville, California 95661 |
Saint John's Cancer Center at Saint John's Medical Center | Anderson, Indiana 46016 |
Mercy Cancer Center at Mercy San Juan Medical Center | Carmichael, California 95608 |
Barnes-Jewish West County Hospital | Saint Louis, Missouri 63141 |
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters | Saint Peters, Missouri 63376 |
Renown Institute for Cancer at Renown Regional Medical Center | Reno, Nevada 89502 |
Norris Cotton Cancer Center - North | Saint Johnsbury, Vermont 05819 |
Northeast Radiation Oncology Center | Dunmore, Pennsylvania 18512 |
Nebraska Medical Center | Omaha, Nebraska 68198 |
Upper Delaware Valley Cancer Center | Milford, Pennsylvania 18337 |
St. Vincent Oncology Center | Indianapolis, Indiana 46260 |