on-randimized confirmatory trial of postoperative concurrent chemoradiotherapy (CCRT) using IMRT for patients with high-risk uterine cervical cancer (JCOG1402, PopCC IMRT-CCRT)
Phase 3
Recruiting
- Conditions
- Postoperative uterine cervical cancer patients with high-risk prognostic factors
- Registration Number
- JPRN-UMIN000027017
- Lead Sponsor
- Japan Clinical Oncology Group (JCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 220
Inclusion Criteria
Not provided
Exclusion Criteria
1) Simultaneous or metachronous (within 5 years) double cancers except carcinoma in situ or intramucosal tumor. 2) Active systemic infections to be treated. 3) Body temperature of 38 or more degrees Celsius 4) Women during pregnancy or possible pregnancy, within 28 days after delivery, or during breast-feeding 5) Severe psychiatric disease 6) Continuous systemic steroid treatment 7) Insulin-dependent or uncontrolled diabetes mellitus 8) Uncontrolled hypertension 9) Unstable angina, or history of myocardial infarction within 6 months 10) HBs antigen or HCV antibody positive 11) HIV antibody positive 12) Interstitial pneumonitis, lung fibrosis or severe emphysema on chest CT
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 3-year relapse free survival
- Secondary Outcome Measures
Name Time Method Overall survival, locoregional-relapse free survival, proportion of >= Grade 3 lower gastrointestinal complication, proportion of lower limb edema, adverse events, serious adverse events