Phase I/II study about nedaplatin plus radiation (external beam + intra-cavitary) for local advanced uterine cervical cancer.
Phase 1
Recruiting
- Conditions
- uterine cervical cancer
- Registration Number
- JPRN-UMIN000007218
- Lead Sponsor
- Department of Radiology, University of Tokyo Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
1. chemotherapy naive 2. pelvic irradiation naive 3. M1 (having distant metastasis) 4. having para-aortic lymph node metastasis 5. having serious coexisting illness 6. having synchronism overlap cancer
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method In step 1, MTD (maximum tolerated dose) and RD(recommended dose) of nedaplatin.
- Secondary Outcome Measures
Name Time Method In stap 2, primary endpoint = response rate and secondary endpoints = safety (occurrence frequency of adverse event), progress free survival, and overall survival.