Uterine cervical cancer
Conditions
Interventions
Administer PTX plus nedaplatin to the patients with stage Ib2 or IIa node-positive cervical cancer for adjuvant chemotherapy.
Sponsors
Kansai Clinical oncology Group (KCOG)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Patients with a histological diagnosis of squamous cell carcinoma of uterine cervix 2) FIGO stage IB2 or IIa patients with invasion to parametrium which was histologically diagnosed 3)Patients with lymph-node metastasis which was histologically diagnosed after radical hysterectomy 4)No residual tumor after hysterectomy 5)No previous treatment for cervical cancer 6)Patients who are 20 years old or older and younger than 75 years old at the enrollment 7)ECOG Performance Status: 0-1 8) Patients who satisfy following organ function Test Reference range Bone marrow function WBC 3,000-12,000/mm3 ANC >=1,500/ mm3 Hb >=9.0g/dL Platelet >=100,000/ mm3 Liver function AST, ALT 2.5 times of institutional upper normal limit or less ALP 2.5 times of institutional upper normal limit or less Bilirubin <1.2mg/dL Renal function Serum creatinine 1.5 times of institutional upper normal limit or less Cardiac function LVEF >=50% ECG within normal limits or no symptoms without the need of treatment 9) Patients who have signed informed consent 10) Patients who are expected to start protocol treatment within 6 weeks after surgery
Exclusion criteria
Exclusion criteria: 1) Patients with para-aortic lymphnode metastasis which was histologically dianosed 2) Patients with surgical martin positive 3) Patients with ovarian or fallopian metastasis 4) Patients with peritoneal metasitasis 5) Patients with motor and/or sensory neurological disfunction 6) Patients with history of hypersensitive reaction to alcohol 7) Patients with active bacterial infection 8) Patients with serious complication 9) Patients with diagnosis of active multiple cancers: exceptions are carcinoma in situ that is curatively treated by local treatment, and intramucosal carcinoma like lesion 10) Patients with interstitial pneumonitis / pulmonary fibrosis 11) Patients with ascites and/or pleural effusion which needs treatment 12) Patients with contraindication of administration of PTX and/or NDP 13 Patients who are decided to be ineligible for this study by the principal investigator ( or subinvestigator )
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2 year progression free survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of adverse events, Compliance of chemotherapy 5 year oveall survival rate 5 year progression free survival rate Rate of the events of lymph-edema of legs | — |
Countries
Japan
Contacts
Public ContactMunetaka Takekuma
Shizuoka Cancer Center Division of Gynecology
Outcome results
None listed