A phase II randomized controlled trial comparing perioperative mFOLFOXIRI with perioperative chemoradiotherapy for locally advanced rectal cancer.
Phase 2
- Conditions
- Rectal cancer
- Registration Number
- JPRN-UMIN000018624
- Lead Sponsor
- Osaka Medical College Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 34
Inclusion Criteria
Not provided
Exclusion Criteria
1. Currently treated with systemic steroids or immunosuppressive agent 2. Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ or mucosal carcinoma 3. Infectious disease to be treated 4. Positive for HBs antigen 5. Uncontrollable hypertension, Uncontrollable diabetes mellitus, Uncontrollable arrhythmia, and severe clinical problem 6. Grade 1 or more peripheral neuropathy 7. Women during pregnancy, possible pregnancy or breast-feeding 8. Severe mental disease 9. Attending physician determines that the case was inappropriate as the subject of this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method RFS:3 years relapse free survival
- Secondary Outcome Measures
Name Time Method Response rate, Proportion of patients with R0 resection, Pathological response, 3 years progression free survival, 3 years overall survival, Incidence of adverse events, Proportion of operative complication, Proportion of anus-preservation without stoma, Evaluation of anal function, Evaluation of bladder function