A Phase II trial of preoperative chemoradiation therapy with S-1 for locally-advanced rectal cancer
- Conditions
- locally advanced rectal cancer (T3-4, N0-2, M0)
- Registration Number
- JPRN-UMIN000015530
- Lead Sponsor
- Department of Surgery, Miyagi Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 15
Not provided
1) Patients with past history of severe drug allergy. 2) Patients with active cancers in other organs or multicentric cancers in colorectum. 3) Contraindication of S-1 administration. 4) Patients who suffered from infection with fever higher than 38 degree. 5) Patients with severe complications such as bowel obstruction, ileus, intestinal pneumonitis or pulmonary fibrosis, uncontrolled diabetes, uncontrolled hypertension, heart failure, renal failure, liver dysfunction and others. 6) Patients with past history of intestinal pneumonitis. 7) Patients with pleural or ascites retention which should be treated. 8) Patients with fresh bleeding from intestinal tract. 9) Patients with watery diarrhea. 10) Women who are willing to pregnancy or possible to be pregnant. Patients who do not intend to prevent pregnancy. 11) Patients who are continuing steroid administration orally or intravenously. 12) Patients with HBs positive. 13) Patients whom doctors consider not to be eligible for this study for some other reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety (incidence and grades of adverse events for preoperative chemoradiation therapy)
- Secondary Outcome Measures
Name Time Method RFS, OS, accumulated local recurrence rate, treatment completion rate, R0 resection rate, down-stagingrate, pathological response rate, response rate (RECIST version1.1), pCR, nutritional assessment, immunohistochemical assessment, safety (operative complications, late adverse events).