Randomized Phase III Trial of the need for adjuvant chemotherapy in stage I epithelial ovarian cancer after comprehensive staging surgery
- Conditions
- Stage I epithelial ovarian cancer after comprehensive staging surgery
- Registration Number
- JPRN-UMIN000008481
- Lead Sponsor
- Japanese Gynecologic Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 360
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival, OS
- Secondary Outcome Measures
Name Time Method Relapse-free survival/Adverse event for adjuvant chemotherapy/Rate of postoperative complications/Treatment or no-treatment for postoperative complications/Number of cycles for planned chemothrapy, histologic type, safety and efficacy for Generic anti-cancer drugs