patients with clinical stage Ib2, IIa(primary tumor diameter
Conditions
Interventions
Cisplatin combined with weekly paclitaxel
Sponsors
Hyogo Cancer Center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Pathologically confirmed uterine crvical cancer 2) Clinical stage Ib2, IIa(primary tumor diameter 4 or more cm),IIb 3) Age from 20 to 75 4) ECOG PS 0-2 5) No prior treatment 6) Normal organ function 7) Written informed consent
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limiting toxicity(phase I trial) 2-year progression free survival, response rate and safety(phase II trial) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, 2-year overall survival, 2 year progression free survival(phase I trial) 2-year overall survival, adverse effect,region of reccurence | — |
Countries
Japan
Contacts
Public ContactMaki Tanioka
Hyogo Cancer Center Medical oncology
Outcome results
None listed