NCT04063527

Phase III Trial of Stage I Ovarian Cancer After Surgery

Randomized Phase III Trial of the Need for Adjuvant Chemotherapy in Stage I Epithelial Ovarian Cancer After Comprehensive Staging Surgery

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Japanese Gynecologic Oncology Group · Academic / Other
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

To compare the Overall survival of adjuvant chemotherapy versus observation in stage I epithelial ovarian cancer after comprehensive staging surgery

Detailed description

Based on the following adjustment factors, patients will be randomly assigned in a 1:1 ratio to adjuvant chemotherapy or observation groups. 1. Histologic type: clear cell adenocarcinoma/mucinous adenocarcinoma vs. serous adenocarcinoma/other histologic types 2. Facility where a subject is enrolled 3. International Federation of Gynecology and Obstetrics(FIGO) clinical staging: Stage Ia/ Ib vs. Stage Ic(b) Group A: adjuvant chemotherapy group (standard treatment group): While one of the following treatments will be performed, the number of cycles is entrusted to the treatment policy of each facility. Paclitaxel plus Carboplatin (TC) therapy; Paclitaxel (PTX) 175 mg/m2 + Carboplatin(CBDCA) area under curve(AUC) 6 q3weeks day1, 3 to 6 cycles Docetaxel plus Carboplatin (DC) therapy; Docetaxel(DTX) 70 mg/m2 + CBDCA AUC 6 q3weeks day1, 3 to 6 cycles After the start of TC therapy, switching from PTX to DTX due to an adverse event is permitted. Group B: observation group (study treatment group): Observation only, no adjuvant chemotherapy administered.

Conditions

• Epithelial Ovarian Cancer

Interventions

Type	Name	Description
DRUG	adjuvant chemotherapy	combination of paclitaxel and carboplatin

Timeline

• Start date: 2012-07-20
• Primary completion: 2029-10-01
• Completion: 2030-02-01
• First posted: 2019-08-21
• Last updated: 2019-08-30

Locations

103 sites across 2 countries: Japan, South Korea