A Phase I/II Study of S-1 and Oxaliplatin Combined With Radiation for Preoperative Locally Advanced Rectal Carcinoma
- Conditions
- Colorectal Cancer
- Registration Number
- JPRN-UMIN000017450
- Lead Sponsor
- Japan Clinical Cancer Research Organization
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 45
Not provided
1) A previous history of serious drug-induced hypersensitivity. 2) A history of radiotherapy of the pelvic cavity. 3) Infection accompanied by a fever of 38.0 degrees C or higher 4) Serious concurrent disease (interstitial pneumonia or pulmonary fibrosis, poorly controlled diabetes mellitus, renal failure, liver failure, etc.). 5) Remarkable electrocardiographic abnormalities or clinically problematic heart disease (heart failure, myocardial infarction, angina pectoris). 6) Sensory neuropathy. 7) Serious diarrhea (watery stool) (however, excluding diarrhea occurring as a defecatory abnormality caused by colorectal cancer). 8) Pleural effusion or ascites that may require puncture to alleviate symptoms. 9) Synchronous multiple primary cancer or metachronous multiple primary cancer with a disease-free survival of 5 years or less (However, patients with early cancer likely to be cured by local treatment will not be excluded.). 10) Women who may (want to) become pregnant, pregnant women, or breast-feeding women. 11) Men who want to have children. 12) Current treatment with flucytosine. 13) In addition, patients who are judged by the responsible study investigator or physician in charge to be inappropriate for enrollment in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I: to determine the dose limiting toxicities (DLTs) and the maximum tolerated dose (MTD) Phase II: pCR rate
- Secondary Outcome Measures
Name Time Method Phase I: pCR rate, R0 resection rate, Down staging rate, Safety Phase II: R0 resection rate, Down staging rate, Local reccurence rate, Disease free survuval, Safety