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NOT YET RECRUITING
NCT04515602
PHASE3

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

Sponsor: Shanghai Gynecologic Oncology Group

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

410

Start Date

2021-01

Completion Date

2028-01

Last Updated

2020-08-27

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

PARPi

For patients with gBRCA/sBRCA mutation and CR/PR after first-line chemotherapy, maintenance therapy of PARP inhibitors.

Locations (4)

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Obstetrics & Gynecology Hospital of Fundan University

Shanghai, China

Shanghai First Maternity and Infant Hospital

Shanghai, China

Shanghai Jiao Tong University School of Medicine Xinhua Hospital

Shanghai, China