Phase II trial of S-1 plus Cetuximab combination chemotherapy for advanced recurrent/metastatic carcinoma of the oral cavity
Phase 2
- Conditions
- Advanced recurrent/metastatic carcinoma of the oral cavity
- Registration Number
- JPRN-UMIN000024371
- Lead Sponsor
- Osaka University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Not provided
Exclusion Criteria
1. History of hypersensitivity for the medicine of this study and the analogues. 2. receiving flucytocine. 3. possibly receiving flucytocine, HIV positive, or HBs antigen positive 4. Active infection requiring treatment. 5. Gastrointestinal disorder requiring treatment (paresis of intestine, ileus, etc). 6. Interstitial Pneumonia, pulmonary fibrosis 7. Uncontrolled diabetes mellitus. 8. Uncontrolled heart failure. 9. Severe liver failure. 10. Pregnant or lactating women or person in hope of the pregnancy of the partner. 11. Decision of ineligibility by a physician.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival
- Secondary Outcome Measures
Name Time Method Progression Free Survival Tumor response rate Safety and adverse event