Phase I/II trial of neoadjuvant chemotherapy with cisplatin and weekly paclitaxel in patients with stage Ib2- IIb uterine cervical cancer
Phase 1
- Conditions
- patients with clinical stage Ib2, IIa(primary tumor diameter4 or more cm),IIb uterine cervical cancer
- Registration Number
- JPRN-UMIN000002636
- Lead Sponsor
- Hyogo Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
1) Usage of other experimental drugs, phenytoin or flucytosine 2) History of serious drug allergy or hypersensitivity with cisplatin or paclitaxel 3) Massive ascites 4) Active infection 5) Peripheral neuropathy 6) Unstable angina, myocardinal infarction within 6 months or serious arrthymia 7) Ileus 8) Interstitial pneumonia or fibrosis 9) Double cancer 10)No coexisting severe medical conditions such as uncontrollable diabetes mellitus, hypertension or bleeding 11) Pregnancy or lactation 12) Mental disease 13) Continuus usage of steroid 14) Bilateral hydronephrosis 15) Judged as inappropriate to participate this trial by investigators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Dose limiting toxicity(phase I trial) 2-year progression free survival, response rate and safety(phase II trial)
- Secondary Outcome Measures
Name Time Method Safety, 2-year overall survival, 2 year progression free survival(phase I trial) 2-year overall survival, adverse effect,region of reccurence