NCT05200260

Surgery Combined With Maintenance Targeted Therapy in the Treatment of Advanced Ovarian Cancer

A Prospective, Multicenter, Randomized Phase II Trial on Optimal Timing of Surgery Combined With Maintenance Targeted Therapy in the Treatment of Advanced Ovarian Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Shanghai Gynecologic Oncology Group · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Optimal Timing of Surgery combined with Maintenance Therapy in the Front-line Treatment of Advanced Ovarian Cancer

Detailed description

The purpose of this trial is to answer the fundamental question 'The Optimal Timing of Surgery' combined with Bevacizumab or Poly-adenosine Ribose Phosphate Inhbitors (PARPi), in the circumstance of primarily diagnosed advanced epithelial ovarian cancer, fallopian tube cancer and primary peritoneal carcinoma.

Conditions

• 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	PARP inhibitor	For patients with BRCA mutated, maintenance therapy of PARP inhibitors following CR/PR after first-line chemotherapy. In this trial, Olaparib 300mg p.o. twice daily is suggested after the front-line therapy.
DRUG	Bevacizumab	For patients without BRCA mutated, maintenance therapy of Bevacizumab following CR/PR after first-line chemotherapy. In this trial, Bevacizumab 7.5mg per kilogram intravenous once every 3 weeks is suggested after the front-line therapy.

Timeline

• Start date: 2022-07-13
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2022-01-20
• Last updated: 2025-02-10

Locations

9 sites across 1 country: China