NCT00207831

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

Trial UFT/RT Randomized Multicenter Phase III Randomized Trial Testing Ftorafur (UFT) Associated With Neoadjuvant Radiotherapy Versus Radiotherapy Alone in Rectal Adenocarcinoma

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 219 (actual)
• Sponsor: Institut Cancerologie de l'Ouest · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Adenocarcinoma of the rectum Stage II/stage III rectal cancer (if T4 only anal extension eligible) Drug: UFT Procedure: chemotherapy Procedure: conventional surgery Procedure: neoadjuvant therapy Procedure: radiation therapy Procedure: radiosensitization Procedure: surgery

Conditions

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

Interventions

Type	Name	Description
DRUG	Tegafur and Uracil

Timeline

• Start date: 2004-07-01
• Primary completion: 2007-06-01
• Completion: 2008-02-01
• First posted: 2005-09-21
• Last updated: 2020-03-25

Locations

27 sites across 1 country: France