The pilot study on surgical safety after neoadjuvant chemotherapy of mFOLFOX6 for locally advanced rectal cancer.
Phase 2
- Conditions
- locally advanced rectal cancer
- Registration Number
- JPRN-UMIN000012559
- Lead Sponsor
- Gastroenterological Surgery I, Hokkaido University Graduate School of Medicine
- Brief Summary
Surgical morbidity (grade 3 or above) occurred in 4 patients (10.5%). Surgery after four courses of mFOLFOX6 chemotherapy can be a safe and promising strategy for patients with locally advanced rectal cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 41
Inclusion Criteria
Not provided
Exclusion Criteria
1. Double cancer 2. Pregnant or lactating women. 3. Patients with a history of colorectal cancer(Excluding mucosal cancer). 4. Patients with peripheral sensory neuropathy(CTCAE v4.0> Grade 1). 5. Patients with infectious disease requiring systemic therapy. 6. Patients with uncontrolable cardiovascular disease. 7. Patients with a history of mental disorder.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method percentage of postoperative complications
- Secondary Outcome Measures
Name Time Method Response rate by preoperative chemotherapy, the safety of preoperative chemotherapy, local recurrence rate, disease-free survival