Stage I epithelial ovarian cancer after comprehensive staging surgery
Conditions
Interventions
combination of paclitaxel and carboplatin
Observation
Sponsors
Japanese Gynecologic Oncology Group
Japanese Gynecologic Oncology Group
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Patients with a diagnosis of histopathologically epithelial ovarian cancer 2) FIGO Stages IA(Grade2/3, clear cell carcinoma), IB(Grade2/3, clear cell carcinoma) and IC1(all degree of differentiation and all histologic type) 3) Patients with a diagnosis of advanced stage by comprehensive staging or restaging laparotomy. 4) Patients who received comprehensive staging surgery (basic surgical techniques (total hysterectomy, bilateral salpingo-oophorectomy, and omentectomy) as well as peritoneal cytology, multiple biopsies of the peritoneum ([Peritoneal biopsy] see details below), retroperitoneal lymph node dissection (see details below [Retroperitoneal lymph node dissection]). However, for the following cases, it is eligible as a condition to record on the official document. * Peritoneal biopsy: peritoneal metastasis is not recognized by macroscopic and palpation in the stipulated site, and the case that biopsy has not been performed. * Retroperitoneal lymph node dissection: the case that lymph nodes of the stipulated range has been dissected however the prescribed number has not been reached. 5) Age: 20 or older 6) Performance status (PS):0-1 7) Case with initial therapy for postoperative primary lesion 8) Patient possible to receive the first study treatment within 8 weeks after the comprehensive staging surgery 9) Reasonable organ function 10) Patient must have signed informed consent.
Exclusion criteria
Exclusion criteria: 1) FIGO Stages IC2, IC3 2) Patients containing sarcoma elements 3) Patients with any signs of interstitial pneumonia or pulmonary fibrosis by chest radiography and CT 4) Patients with serious complications 5) Patients with active infection 6) Patients with intestinal paralysis or intestinal obstruction 7) Patients who have a synchronous malignancy or who have been progression-free less than 5 years for a metachronous malignancy 8) Patients with previous chemotherapy or radiation therapy 9) Patients with serious drug hypersensitivity 10) Patients with peripheral motor/sensory neuropathy (grade2,3,4 CTC-AE 4.0) 11) Patients who have had a hypersensitivity reaction to polyoxyethylated or hydrogenated castor oil 12) Patients with positive HBsAg.Patients with more than 2.1 log/copies ml based on fixed HBV-DNA who are positive with either antigen-positive HBs, anti-hepatitis B core antigen or anti-hepatitis B surface antigen. 13) Patients who are inappropriate to enter this study with any safety reasons, judged by the treating physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-specific Survival (DSS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS) Relapse free survival (RFS) Incidence rate of adverse events in the adjuvant chemotherapy group Incidence rate of postoperative complications (early and late stage) Treatment (including surgery) or no treatment for complications Incidence rate of second cancers Relationship between prognosis and the following items (subset analysis) Planned chemotherapy cycles Histologic type | — |
Countries
Japan,Asia(except Japan)
Contacts
Public ContactHiroshi Tanabe
JGOG3020 Coordinating Office National Cancer Center Hospital East ,gynecology
Outcome results
None listed