Trial UFT/RT Randomized Multicenter Phase III Randomized Trial Testing Ftorafur (UFT) Associated With Neoadjuvant Radiotherapy Versus Radiotherapy Alone in Rectal Adenocarcinoma (UFT RT Phase 3)

NCT00207831 Phase 3 TERMINATED

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.

Details

Lead sponsor	Institut Cancerologie de l'Ouest
Phase	Phase 3
Status	TERMINATED
Enrolment	219
Start date	2004-07
Completion	2008-02

Conditions

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

Interventions

• Tegafur and Uracil

Primary outcomes

• Compare the rate of pathologic complete response of the primary tumor in patients with operable rectal cancer receiving preoperative chemoradiotherapy versus patients receiving radiotherapy alone

Countries

France