Phase II study of neoadjuvant mFOLFOX6 (+ cetuximab) in patients with resectable pelvic recurrences after rectal cancer surgery
Phase 2
- Conditions
- Recurrent rectal cancer
- Registration Number
- JPRN-UMIN000009583
- Lead Sponsor
- ational Cancer Center Hospital East
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 33
Inclusion Criteria
Not provided
Exclusion Criteria
1) Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval 2) Severe infectious disease 3) Patients who receive steroid continuously are excluded 4) Unstable angina or myocardial infarction within 6 months 5) Interstitial pneumonia or fibroid lung 6) Women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test 7) Those considered inappropriate for participation in this trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method R0 resection rate
- Secondary Outcome Measures
Name Time Method Disease-free survival Overall survival Safety Response rate Histological Response