Stratified Evaluation of PDS and NACT-IDS in Ovarian Cancer (FOCUS)
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Epithelial Ovarian Cancer
- Fallopian Tube Cancer
- Primary Peritoneal Carcinoma
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
OBJECTIVES: Compare the efficacy and safety in patients with advanced ovarian cancer treated with NACT-IDS versus PDS, among different tumor burden groups. Compare survival benefit of PARPi therapy in patients treated with PDS or NACT-IDS. OUTLINE: This is a randomized phase III multicenter study. P...
OBJECTIVES: Compare the efficacy and safety in patients with advanced ovarian cancer treated with NACT-IDS versus PDS, among different tumor burden groups. Compare survival benefit of PARPi therapy in patients treated with PDS or NACT-IDS. OUTLINE: This is a randomized phase III multicenter study. Patients will receive upfront maximal cytoreductive surgery followed by at least 6 cycles of adjuvant chemotherapy or 3 cycles of neoadjuvant chemotherapy followed by interval debulking surgery, and then at least 3 cycles of adjuvant chemotherapy, and maintenance therapy of PARP inhibitor for patients with gBRCA/sBRCA mutation who had a complete or partial clinical response after platinum-based chemotherapy. Patients are followed every 3 months within the first 5 years, and then every 6 months. PROJECTED ACCRUAL: A total of 410 patients will be accrued for this study within 3 years.
Tracking Information
- NCT #
- NCT04515602
- Collaborators
- Obstetrics & Gynecology Hospital of Fudan University
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Shanghai First Maternity and Infant Hospital
- Investigators
- Not Provided
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