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

• Status: Terminated
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ICO Paul Papin; Institut Cancerologie de l'Ouest
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Tegafur

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed invasive adenocarcinoma of the rectum , M0, lower side < 10 cm from anal verge

• T3 or T4 disease (T4 exclusive anal extension )

PATIENT CHARACTERISTICS:

Performance status

• ECOG 0-2 OR

• Zubrod 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count > 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

Hepatic

• Bilirubin < x2 UNL

Renal

• Creatinine < 150 µMol/L

Gastrointestinal

• No history of inflammatory bowel disease

• No history of difficulty or inability to take or absorb oral medications

Neurologic

• Not specified

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No other malignancy within the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the cervix

• No history of psychiatric conditions or diminished mental capacity that would preclude study compliance or giving informed consent

PRIOR CONCURRENT THERAPY:

Chemotherapy

• No prior chemotherapy

Radiotherapy

• No prior radiotherapy to the pelvis

Other

• No other concurrent investigational drugs

• No other concurrent anticancer treatment