Cervical cancer patients with clinical stage IB2, IIA, IIB
Conditions
Interventions
Sponsors
Sankai Gynecology Study Group
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 70 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, ileus 4) Active infection 5) Peripheral neuropathy grade 2-4 6) Unstable angina, myocardinal infarction within 6 months or serious arrthymia 7) Interstitial pneumonia or fibrosis 8) Double cancer 9) No coexisting severe medical conditions such as uncontrollable diabetes mellitus, hypertension or bleeding 10) Pregnancy or lactation 11) Mental disease 12) Continuus usage of steroid 13) Bilateral hydronephrosis 14) Judged as inappropriate to participate this trial by investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year recurrence-free survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| response rate of neoadjuvant dose dense TP, pathologic complete response rate, safety, 2-year overall survival rate, adverse events, site of recurrence | — |
Countries
Japan
Contacts
Public ContactMaki Tanioka
Hyogo Cancer Center Medical Oncology
Outcome results
None listed