Postoperative Evaluation of 5-FU by Bolus Injection vs. 5-FU by Prolonged Venous Infusion Prior to and Following Combined Prolonged Venous Infusion Plus Pelvic XRT vs. Bolus 5-FU Plus Leucovorin Plus Levamisole Prior to and Following Combined Pelvic XRT Plus Bolus 5-FU Plus Leucovorin in Patients With Rectal Cancer, Phase III
OBJECTIVES: I. Compare the overall and relapse free survival of patients with stage II or
III rectal cancer treated with one of the following three regimens: bolus injections of
fluorouracil (5-FU) prior to and following pelvic irradiation plus protracted venous
infusion (PVI) 5-FU radiosensitization vs PVI 5-FU prior to and following pelvic irradiation
plus PVI 5-FU radiosensitization vs bolus 5-FU with leucovorin calcium and levamisole prior
to and following pelvic irradiation. II. Describe relapse patterns and tolerance associated
with these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to type
of prior surgery (abdominoperineal resection vs anterior resection), nodal status (N0 vs N1
vs N2-3), depth of tumor invasion (T1-2 vs T3 vs T4a vs T4b), time from surgery to study
entry (20-45 days vs 46-70 days), participating center, and performance status (0-1 vs 2).
Patients are randomized to one of three treatment arms. Arm I: Patients receive fluorouracil
(5-FU) IV on days 1-5 and 29-33. 5-FU is then given as a continuous infusion beginning on
day 57 and continuing concurrently with radiotherapy for 5 weeks. Following a 28 day break
from treatment patients receive 5-FU IV on days 1-5 of a 28 day course. Postradiotherapy
treatment repeats for a total of 2 courses in the absence of disease progression or
unacceptable toxicity. Arm II: Patients receive 5-FU IV continuously on days 1-42. 5-FU and
radiotherapy are then administered as in arm II. Arm III: Patients receive leucovorin
calcium (CF) IV followed by 5-FU IV on days 1-5 and 29-33. Patients also receive oral
levamisole twice daily on days 1-3, 15-17, 29-31, and 43-45. CF IV and 5-FU IV are then
given on days 57-60 and 85-88 concurrently with radiotherapy. Following a 28 day break from
treatment patients receive CF IV and 5-FU IV on days 1-5 and 29-33 and oral levamisole twice
daily on days 1-3, 15-17, 29-31, and 43-45 in the absence of disease progression or
unacceptable toxicity. All patients receive radiotherapy 5 days per week for 5 weeks
starting on day 57. Patients are followed every 4 months for 2 years, then every 6 months
for 4 years, and then annually until death.
PROJECTED ACCRUAL: A total of 1,800 patients (600 per arm) will be accrued for this study.
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Survival and Relapse-free survival
Until death
No
Stephen R. Smalley, MD
Study Chair
University of Kansas
United States: Federal Government
CDR0000063349
NCT00002551
March 1994
October 2008
Name | Location |
---|---|
Albert Einstein Comprehensive Cancer Center | Bronx, New York 10461 |
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
CCOP - Ann Arbor Regional | Ann Arbor, Michigan 48106 |
University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Colorado Cancer Research Program, Inc. | Denver, Colorado 80209-5031 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Veterans Affairs Medical Center - East Orange | East Orange, New Jersey 07018-1095 |
CCOP - Northern New Jersey | Hackensack, New Jersey 07601 |
Hahnemann University Hospital | Philadelphia, Pennsylvania 19102-1192 |
CCOP - Duluth | Duluth, Minnesota 55805 |
CCOP - Scottsdale Oncology Program | Scottsdale, Arizona 85259-5404 |
CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
Siouxland Hematology-Oncology | Sioux City, Iowa 51101-1733 |
CCOP - Ochsner | New Orleans, Louisiana 70121 |
Quain & Ramstad Clinic, P.C. | Bismarck, North Dakota 58501 |
CCOP - Merit Care Hospital | Fargo, North Dakota 58122 |
Altru Health Systems | Grand Forks, North Dakota 58201 |
CCOP - Toledo Community Hospital Oncology Program | Toledo, Ohio 43623-3456 |
CCOP - Geisinger Clinical and Medical Center | Danville, Pennsylvania 17822-2001 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee, Wisconsin 53295 |
CCOP - Evanston | Evanston, Illinois 60201 |
CCOP - Marshfield Medical Research and Education Foundation | Marshfield, Wisconsin 54449 |
Veterans Affairs Medical Center - Chicago (Lakeside) | Chicago, Illinois 60611 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |