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Trial Testing Ftorafur (UFT) Associated With Neoadjuvant Radiotherapy Versus Radiotherapy Alone in Rectal Adenocarcinoma

NCT00207831 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 219

Last updated 2020-03-25

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy, such as 5-fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing and also as a radiosensibilisant. Radiation therapy uses high-energy x-rays to kill tumor cells. 5-fluorouracil may make tumor cells more sensitive to radiation therapy. Oral 5-fluorouracil is more convenient for ambulatory patients. Giving UFT (Tegafur and Uracil) with radiation therapy before surgery may shrink the tumor so it can be removed.

PURPOSE: This phase III trial is studying how well giving UFT with radiation therapy works in treating patients who are undergoing surgery for operable rectal cancer.

Conditions

  • Rectal Cancer
  • Stage II/III
  • T3 or T4 (Only Anal Extension) Rectal Cancer
  • N0-2
  • M0

Interventions

DRUG

Tegafur and Uracil

Sponsors & Collaborators

Principal Investigators

  • Patrice Cellier, MD · Institut Cancerologie de l'Ouest

  • Rémy Barraya, MD · Institut Cancerologie de l'Ouest

  • Christian Chevelle, MD · Centre des Hautes Energie, Toulouse

  • Gérard Lorimier, MD · Institut Cancerologie de l'Ouest

  • Véronique Verrièle, MD · Institut Cancerologie de l'Ouest

  • Michèle Boisdron, Pct, PhD · Institut Cancerologie de l'Ouest

  • Loïc Campion, MD · Centre René Gauducheau, Nantes

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-07-31
Primary Completion
2007-06-30
Completion
2008-02-29

Countries

  • France

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00207831 on ClinicalTrials.gov