A Phase II/III Randomized multicenter Trial of Intersphincteric resection (ISR) with or without Preoperative Chemotherapy for very low-lying Rectal Cancer(UMIN9510) -Additional study: How to predict the chemotherapy response
Not Applicable
- Conditions
- Very Low Rectal Cancer
- Registration Number
- JPRN-UMIN000030226
- Lead Sponsor
- ational Defense Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients with request of abdominoperineal resection (APR) 2) Patients with impossibility for ISR 3) Patients with poor anal function preoperatively 4) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in site or mucosal carcinoma 5) Patients with serious diseases as follows i. Uncontrollable diabetes mellitus ii. Uncontrollable hypertension iii. Interstitial pneumonia, pulmonary fibrosis, or severe emphysema 6) Chronic active hepatitis type B. Positive for HCV 7) Episodes of blood transfusion within the post 14 days 8) Patients with severe mental disease 9) Cannot agree on this study 10) Unsuitable patients for this study
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pathological Complete Response rate Tumor regression grade
- Secondary Outcome Measures
Name Time Method Relapse free survival (RFS) Overall survival (OS) Rate of local recurrence