Phase 1 clinical trial on the safety and efficacy of the negative-balance isolated pelvic perfusion (NIPP) for pelvic malignancy (uterine cervical cancer)
- Conditions
- terine cervical cancer
- Registration Number
- JPRN-UMIN000025351
- Lead Sponsor
- ippon medical school hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 27
Not provided
1) Initial conventional therapy was not performed although indicated. 2) No measurable lesion according to RECIST ver 1.1 3) History of severe allergic reaction to iodine contrast media or platinum derivatives. 4) Impossible to catheterize due to hostile vascular anatomy 5) Contraindication to general anesthesia 6) History of heparin-induced thrombocytopenia 7) Presence of uncontrolled multiple neoplasm 8) Interstitial pneumonitis, pulmonary fibrosis, advanced emphysema, uncontrolled diabetes mellitus, uncontrolled hypertension, severe cardiac disease (heart failure, myocardial infarction, angina pectoris, etc...) with marked ECG abnormality, persistent adverse events (CTCAE ver 4.0 Grade 3 or worse) 9) Contraindication to drugs used in this study 10) Patients whom chief researcher or associate researcher judges unsuitable for this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of dose limiting toxicity in dose-ranging study Objective response rate 6 months after the first NIPP session with the recommended dose
- Secondary Outcome Measures
Name Time Method Objective response rate 6 months after the.first NIPP session Progression free survival Overall survival Time to treatment failure Estimation of maximum tolerated dose Incidence of neuropathy Drug extraction rate Correlation between serum cisplatin concentration and pelvic volume in each dose