Radiation Therapy Plus Chemotherapy Before Surgery With or Without Chemotherapy After Surgery in Treating Patients With Rectal Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, giving the drugs in different ways, and combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus fluorouracil and leucovorin before surgery given with or without fluorouracil and leucovorin after surgery in patients with locally advanced rectal cancer.
Drug: leucovorin calcium
Procedure: conventional surgery
Radiation: low-LET cobalt-60 gamma ray therapy
Radiation: low-LET photon therapy
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||RANDOMIZED TRIAL OF CONCOMITANT PREOPERATIVE RADIO-CHEMOTHERAPY WITH OR WITHOUT POSTOPERATIVE CHEMOTHERAPY IN LOCALLY ADVANCED RECTAL CARCINOMA|
|Study Start Date:||September 1993|
OBJECTIVES: I. Assess the local recurrence rate, cost-benefit ratio, and acute and late toxicity associated with concomitant preoperative radiotherapy and fluorouracil/leucovorin (5-FU/CF) in patients with locally advanced adenocarcinoma of the rectum. II. Compare the relapse rate, survival rate, disease-free interval, and cost-benefit ratio associated with 6 courses of postoperative 5-FU/CF vs. no further treatment in these patients.
OUTLINE: This is a randomized study. Patients are stratified by tumor stage, age, type of surgery, and participating institution. Patients are randomly assigned to one of two groups. The first group receives radiotherapy to the tumor over 5 weeks and concomitant fluorouracil/leucovorin for 5 consecutive days on the first and fifth weeks. Four to six weeks later, patients undergo complete resection, followed upon recovery by fluorouracil/leucovorin every 4 weeks for 6 courses. The second group receives preoperative chemoradiotherapy followed by surgery, as above, with no postoperative treatment. Patients are followed for survival.
PROJECTED ACCRUAL: A total of 774 patients will be entered on this multicenter study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002896
|Ospedale St. Santa Chiara|
|Pisa, Italy, 56100|
|Study Chair:||Luca Cionini, MD||Santa Chiara Hospital|