Phase 1 trial of neoadjuvant chemotherapy with S1 plus radiation in patients with locally advanced rectal cancer
- Conditions
- rectal cancer
- Registration Number
- JPRN-UMIN000003382
- Lead Sponsor
- Toho University School of Medicine
- Brief Summary
All patients achieved the planned 45 gray of radiation therapy There was no grade 3 toxicity The recommended dose of S-1 was determined to be 80 mg/day The dose intensity of S-1 was well maintained and the combination of S-1 plus radiation therapy was well tolerated by all patients Sphincter preserving procedures were possible in all but one (89%) patient High rates of tumor shrinkage and nodular downstaging were achieved The histological response rate was 78% including one complete response
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 12
Not provided
1.Impossible to receive TS-1 contained chemotherapy 2.Recieving the radiation therapy in a pelvis 3.Infection 4.Serious complications 5.Myocardial infarction within the last 6 months, previous serious medical illness or allergy for drug 6.Multiple malignancies 7. Pleural effusion or ascites requiring 8.Current or previous Brain metastasis 9.Diarrhea(watery stool) 10.Fresh bleeding of digestive organs 11.Need to treatment with flucytosine, atazanavir sulfate, or warfalin 12.Evidence of psychiatric disability interfering with enrollment to clinical trial 13.Pregnant or lactating women, women who are capable of pregnancy or intend to get pregnant 14.Man of wanting child 15.Need Systemically administration of corticosteroids 16.Patients judged inappropriate for this study by the physicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maximum tolerated dose Recommended dose
- Secondary Outcome Measures
Name Time Method