NCT00002896

Radiation Therapy Plus Chemotherapy Before Surgery With or Without Chemotherapy After Surgery in Treating Patients With Rectal Cancer

RANDOMIZED TRIAL OF CONCOMITANT PREOPERATIVE RADIO-CHEMOTHERAPY WITH OR WITHOUT POSTOPERATIVE CHEMOTHERAPY IN LOCALLY ADVANCED RECTAL CARCINOMA

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 774 (estimated)
• Sponsor: European Institute of Oncology · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	chemotherapy
DRUG	fluorouracil
DRUG	leucovorin calcium
PROCEDURE	conventional surgery
RADIATION	low-LET cobalt-60 gamma ray therapy
RADIATION	low-LET photon therapy

Timeline

• Start date: 1993-09-01
• First posted: 2004-05-13
• Last updated: 2013-09-20

Locations

1 site across 1 country: Italy