Phase II study of Concurrent Chemoradiotherapy using Nedaplatin for Locally Advanced Uterine Cervical Carcinoma: Kitasato Gynecologic Radiation Oncology Group 0501 (KGROG0501)
Phase 2
- Conditions
- ocally Advanced Uterine Cervical Carcinoma
- Registration Number
- JPRN-UMIN000025688
- Lead Sponsor
- Kitasato Gynecologic Radiatoin Oncology Group (KGROG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 45
Inclusion Criteria
Not provided
Exclusion Criteria
1)Active other cancers except carcinoma in situ or contorolled for more than 2 years, 2)Use of long-term and continuous steroid, 3)Serios complications (heart disease within 3 months, chronic heart failure, neurovascular disease wtih 3 months, uncontrolled disease), 4) para-aortic lymph node swelling (>= 10mm assessed by abdominal computed tomography), 5)Judged to be ineligible for this protocol by the attending physicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 3-year overall survival
- Secondary Outcome Measures
Name Time Method initial tumor response, protocol completion rate, 2-year overall survival rate, 2- and 3-year overall survival rate, 3-year loco-regional contorol rate, pattern of failure(initial site), acute adverse events(based on CTCAE ver3.0: hematological and non-hematological), late adverse events (based on RTOG/EORTC late radiatoin morbidity scoring schema: small instestine/colon, rectum, bladder)