Radiation Therapy, Surgery, and Chemotherapy in Treating Patients With Rectal Cancer That Can Be Surgically Removed

Phase 3

Completed

• Conditions: Colorectal Cancer

• Registration Number: NCT00002523
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Brief 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 radiation therapy and surgery with chemotherapy may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare radiation therapy alone before surgery with radiation therapy plus fluorouracil and leucovorin before surgery, with and without fluorouracil and leucovorin after surgery in patients with rectal cancer that can be surgically removed.

Detailed Description

OBJECTIVES:

* Compare the disease-free and overall survival in patients with resectable adenocarcinoma of the rectum treated with preoperative radiotherapy with or without preoperative fluorouracil (5-FU) combined with leucovorin calcium (CF) and/or postoperative 5-FU/CF.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, sex, tumor location (0-5 vs 6-10 vs 11-15 cm from anal margin), and stage (T3 vs T4). Patients are randomized to 1 of 4 treatment arms.

* Arm I: Patients undergo involved-field radiotherapy 5 days a week for 5 weeks followed 3-10 weeks later by abdominoperineal resection or anal-sparing resection according to local practice in the absence of disease progression or unacceptable toxicity.

* Arm II: Patients undergo radiotherapy as in arm I beginning on day 1 and leucovorin calcium (CF) IV followed by fluorouracil (5-FU) IV (1 hour before radiotherapy) on days 1-5 and 29-33, followed 3-10 weeks later by resection as in arm I in the absence of disease progression or unacceptable toxicity.

* Arm III: Patients undergo radiotherapy followed 3-10 weeks later by resection as in arm I. Within 3-10 weeks after resection, patients receive CF followed by 5-FU on days 1-5. Chemotherapy continues every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.

* Arm IV: Patients undergo preoperative radiotherapy with concurrent chemotherapy followed by resection as in arm II and postoperative chemotherapy as in arm III.

Patients are followed every 6 months.

PROJECTED ACCRUAL: A total of 992 patients will be accrued for this study within 4 years.

Study Timeline

• Study Start: 1993-04
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2003-03
• Study Completion: 2016-01
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-01
• Last Update Posted: 2016-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1011

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (35)

Hopital Universitaire Erasme; 🇧🇪 Brussels, Belgium

Hopital Civil de Charleroi; 🇧🇪 Charleroi, Belgium

Clinique Sainte Elisabeth; 🇧🇪 Namur, Belgium

Institut Jules Bordet; 🇧🇪 Brussels, Belgium

Centre Hospitalier General; 🇫🇷 Belfort, France

Institut Sainte Catherine; 🇫🇷 Avignon, France

Centre Hospitalier Universitaire de Tivoli; 🇧🇪 La Louviere, Belgium

C.H.U. de Brest; 🇫🇷 Brest, France

Centre Paul Papin; 🇫🇷 Angers, France

Hospital General Gregorio Maranon; 🇪🇸 Madrid, Spain

Centre Hospital Regional Universitaire de Limoges; 🇫🇷 Limoges, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Centre Saint-Yves; 🇫🇷 Vannes, France

CHR de Grenoble - La Tronche; 🇫🇷 Grenoble, France

Clinique De Valdegour; 🇫🇷 Nimes, France

Centre Hospitalier Universitaire Henri Mondor; 🇫🇷 Creteil, France

Institut Catala d'Oncologia - Hospital Duran i Reynals; 🇪🇸 Barcelona, Spain

CHR de Besancon - Hopital Jean Minjoz; 🇫🇷 Besancon, France

Centre de Lutte Contre le Cancer, Georges-Francois Leclerc; 🇫🇷 Dijon, France

Krankenhaus des Kreises Hameln-Pyrmont; 🇩🇪 Hameln, Germany

Service Cancerologie Polyclinique Clairval; 🇫🇷 Marseille, France

CRLCC Nantes - Atlantique; 🇫🇷 Nantes-Saint Herblain, France

Hopital Jean Bernard; 🇫🇷 Poitiers, France

Clinique Sainte Clotilde; 🇫🇷 Sainte Clotilde, France

Centre Hospitalier Universitaire Bretonneau de Tours; 🇫🇷 Tours, France

Centre Paul Strauss; 🇫🇷 Strasbourg, France

Rambam Medical Center; 🇮🇱 Haifa, Israel

University Medical Center Nijmegen; 🇳🇱 Nijmegen, Netherlands

Dr. Bernard Verbeeten Instituut; 🇳🇱 Tilburg, Netherlands

Medical University of Gdansk; 🇵🇱 Gdansk, Poland

Hospital General Universitari Vall d'Hebron; 🇪🇸 Barcelona, Spain

Institute of Oncology and Radiology of Serbia; 🇷🇸 Belgrade, Serbia

UniversitaetsSpital; 🇨🇭 Zurich, Switzerland

Dokuz Eylul University School of Medicine; 🇹🇷 Izmir, Turkey

Kantonsspital Basel; 🇨🇭 Basel, Switzerland