RecruitingPhase 2NCT05200260

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

Sponsor

Shanghai Gynecologic Oncology Group

Enrollment

220 participants

Start Date

Jul 13, 2022

Study Type

INTERVENTIONAL

Conditions

Ovarian Cancer Primary Peritoneal Carcinoma Fallopian Tube Cancer

Summary

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

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether surgery combined with ongoing targeted therapy (PARP inhibitors) improves outcomes in advanced ovarian cancer. Researchers are focusing on patients who can achieve complete tumor removal and then continue targeted therapy as maintenance. **You may be eligible if...** - You are a woman 18 or older - You have been diagnosed with advanced ovarian, fallopian tube, or primary peritoneal cancer (stage IIIC or IV) - Doctors believe complete surgical removal of visible tumors is achievable based on your scans - You are in adequate physical health and your blood/organ function meets requirements - You agree to BRCA and HRD genetic testing **You may NOT be eligible if...** - Complete removal of your tumor is not considered possible - You have already received multiple lines of chemotherapy for this cancer - Your organ function is inadequate for surgery and chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREPrimary 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.

PROCEDURENeoadjuvant 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.

DRUGPARP 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.

DRUGBevacizumab

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.