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RECRUITING
NCT05200260
PHASE2

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

Sponsor: Shanghai Gynecologic Oncology Group

View on ClinicalTrials.gov

Summary

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

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

220

Start Date

2022-07-13

Completion Date

2027-06

Last Updated

2025-02-10

Healthy Volunteers

No

Interventions

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.

Locations (9)

The First People's Hospital of Foshan

Foshan, China

Sun Yet-Sen University Cancer Center

Guangzhou, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, China

Zhejiang Cancer Hospital

Hangzhou, China

The First Affiliated Hospital of University of Science and Technology of China

Hefei, China

Fudan University Cancer Hospital

Shanghai, China

Obstetrics and Gynecology Hospital of Fundan University

Shanghai, China

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

Zhongshan Hospital, Fudan University

Shanghai, China