Actively Recruiting
Randomized Phase III Study Comparing Adjuvant Chemotherapy and Observation in Women with Stage I Epithelial Ovarian Cancer After Complete Surgery
Led by Japanese Gynecologic Oncology Group · Updated on 2019-08-30
360
Participants Needed
103
Research Sites
17 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the overall survival of patients with stage I epithelial ovarian cancer after they have undergone comprehensive staging surgery. This phase III trial compares the outcomes of adjuvant chemotherapy versus observation alone. The study aims to determine whether adding chemotherapy after surgery improves survival in this patient group. Participants will be randomly assigned to one of two groups. One group receives adjuvant chemotherapy, which includes either a combination of paclitaxel and carboplatin or docetaxel and carboplatin, given every three weeks for three to six cycles. Switching between paclitaxel and docetaxel is allowed if adverse events occur. The other group undergoes observation without chemotherapy. During the study, participants will be monitored for overall survival up to 60 months from randomization. Researchers will also assess relapse-free survival within the same timeframe. Evaluations include follow-ups to track disease progression, side effects, and general health. The study ensures participants receive appropriate care and measures outcomes to better understand treatment benefits and risks.
CONDITIONS
Brief Title
Phase III Trial of Stage I Ovarian Cancer After Surgery
Research Team
H
Hiroshi Tanabe, M.D.
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