NCT04515602

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

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 410 (estimated)
• Sponsor: Shanghai Gynecologic Oncology Group · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epithelial Ovarian Cancer
• Fallopian Tube Cancer
• Primary Peritoneal Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Primary debulking surgery	Primary debulking surgery with a maximum cytoreduction, then followed by 6 cycles of Paclitaxel 175mg/m2 or Docetaxel 60-75 mg/m2 plus Carboplatin AUC (area under the curve) 5.
PROCEDURE	Neoadjuvant chemotherapy	3 cycles of Paclitaxel 175mg/m2 or Docetaxel 60-75 mg/m2 plus Carboplatin AUC (area under the curve) 5, Interval debulking surgery with a maximal cytoreduction of complete gross resection, then followed by another 3 cycles of chemotherapy.
DRUG	PARPi	For patients with gBRCA/sBRCA mutation and CR/PR after first-line chemotherapy, maintenance therapy of PARP inhibitors.

Timeline

• Start date: 2021-01-01
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2020-08-17
• Last updated: 2020-08-27

Locations

4 sites across 1 country: China