Multicenter phase I trial of the preoperative UFT/LV medical treatment and radiotherapy for the resectable T3 and T2N1-2 rectum cancer

UMIN ID: UMIN000001982

Registered date:19/05/2009

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Rectal Cancer
• Date of first enrollment: 2009/04/01
• Target sample size: 6
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Chemotherapy: UFT:240, 300 mg/m2/day LV:75 mg/body/day Day 1-28 Radiotherapy: 1.8 Gy/day, Day 1-5 every 7 days, 25 times, total 45Gy

Outcome(s)

• Primary Outcome: The decision of maximal tolerated dose (MTD) and recommended dose (RD) of UFT Safety (the degree and grade of the adverse event and the surgical complication)
• Secondary Outcome: Antitumor effect (objective response rate) The rate of pathological CR

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: (1) The case with a serious myelosuppression (2) The case that it is clear to have pneumonitis, pulmonary fibrosis with a chest x-ray film, or the case having these anamneses (3) The pleural or pericardial effusion requiring drainage (The case to need tube drainage or waste fluid by the puncture) (4) The case with the double cancer (The cancer in the epithelium and the skin cancer are removed.) (5) The infectious disease, the intestinal paralysis and the ileus (6) Diarrhea (water-like mail) (7) It is during treatment or a control poor diabetes case by continuous use of the insulin (8) The case having a complication (heart failure, liver failure, renal failure) (9) The brain metastasis case of the existence symptom (10) The pregnant or nursing patients and patients who may be a pregnant (11) The case with having experienced serious drug allergy in the past (12) Exclude the patients who are recognized as inadequate patients by doctors with responsibility in this trial

Related Information

• Primary Sponsor: Division of Gastrointestinal Surgery, Kobe University Hospital
• Source(s) of Monetary Support: None