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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
219
Clinique Sainte Catherine
Avignon, France
Hopital Avicenne
Bobigny, France
Institut de Cancérologie et d'Hématologie
Brest, France
Centre Hospitalier
Brive-la-Gaillarde, France
Centre d'Oncologie-radiothérapie d'Eure et Loir
Chartres, France
Centre Jean Perrin
Clermont-Ferrand, France
Centre Médical République
Clermont-Ferrand, France
Clinique du Mail
Grenoble, France
Centre Hospitalier Départemental
La Roche-sur-Yon, France
Centre Guillaume le Conquérant
Le Havre, France
...and 17 more locations
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
Compare endoscopic ultrasonographic response in patients with operable rectal cancer receiving preoperative chemoradiotherapy versus patients receiving radiotherapy alone.
Compare quality of life (Quality of Life Questionnaire Core 30 Items [QLQ-C 30])
Compare the rate of sphincter conservation alone.
Compare the safety of the chemoradiotherapy regimen to radiotherapy alone
Compare the rate of resectability with negative resection margins in patients treated with this two regimen.
Compare recurrence free survival and disease free survival
Compare overall survival
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