Multicenter phase I trial of the preoperative UFT/LV medical treatment and radiotherapy for the resectable T3 and T2N1-2 rectum cancer
- Conditions
- Rectal Cancer
- Registration Number
- JPRN-UMIN000001982
- Lead Sponsor
- Division of Gastrointestinal Surgery, Kobe University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 6
Not provided
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method Antitumor effect (objective response rate) The rate of pathological CR