Spots Global Cancer Trial Database for Stratified Evaluation of PDS and NACT-IDS in Ovarian Cancer (FOCUS)

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Trial Identification

Brief Title: Stratified Evaluation of PDS and NACT-IDS in Ovarian Cancer (FOCUS)

Official Title: Stratified Evaluation and Prediction of Survival Benefit for PDS or NACT-IDS in Advanced Ovarian Cancer, A Randomized, Phase 3 Trial After the SUNNY Study

Study ID: NCT04515602

Conditions

Epithelial Ovarian Cancer

Fallopian Tube Cancer

Primary Peritoneal Carcinoma

Interventions

Primary debulking surgery

Neoadjuvant chemotherapy

PARPi

Study Description

Brief Summary: The purpose of this study is to answer the fundamental question 'The Optimal Timing of Surgery' in advanced ovarian cancer patients with different tumor burden, and to perform translational study.

Detailed 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. 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.