Phase III Trial of Stage I Ovarian Cancer After Surgery
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Epithelial Ovarian Cancer
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 20 years and 125 years
- Gender
- Only males
Description
Based on the following adjustment factors, patients will be randomly assigned in a 1:1 ratio to adjuvant chemotherapy or observation groups. Histologic type: clear cell adenocarcinoma/mucinous adenocarcinoma vs. serous adenocarcinoma/other histologic types Facility where a subject is enrolled Intern...
Based on the following adjustment factors, patients will be randomly assigned in a 1:1 ratio to adjuvant chemotherapy or observation groups. Histologic type: clear cell adenocarcinoma/mucinous adenocarcinoma vs. serous adenocarcinoma/other histologic types Facility where a subject is enrolled 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.
Tracking Information
- NCT #
- NCT04063527
- Collaborators
- Korean Gynecologic Oncology Group
- Investigators
- Study Chair: Hiroshi Tanabe, M.D. National Cancer Center Hospital East
Get Well Soon