JROSG 10-2
Phase 2
- Conditions
- squamous cell carcinoma of the anal canal
- Registration Number
- JPRN-jRCTs041180053
- Lead Sponsor
- Murofushi Keiko
- Brief Summary
The number of patients statistically required for this study was 36; however, 31 patients were enrolled as the supply of MMC was suspended from October 2019 onward. Good DFS (primary endpoint) with a low rate of late adverse events was observed, and good results of secondary endpoints such as overall survival, local control and colostomy free survival also were obtained.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 31
Inclusion Criteria
anal canal cancer patients, cT1-4N0-3M0
Exclusion Criteria
Previously irradiated for pelvis, malignant tumor history
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 2years disease free survival
- Secondary Outcome Measures
Name Time Method Over all survival, Local control rate, colostomy free survival, toxicity