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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

410

Participants

Timeline

Start Date

January 31, 2021

Primary Completion Date

January 31, 2028

Study Completion Date

January 31, 2028

Conditions
Epithelial Ovarian CancerFallopian Tube CancerPrimary Peritoneal Carcinoma
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.

Trial Locations (4)

200032

Zhongshan Hospital Fudan University, Shanghai

Unknown

Obstetrics & Gynecology Hospital of Fundan University, Shanghai

Shanghai First Maternity and Infant Hospital, Shanghai

Shanghai Jiao Tong University School of Medicine Xinhua Hospital, Shanghai

All Listed Sponsors
collaborator

Obstetrics & Gynecology Hospital of Fudan University

OTHER

collaborator

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

collaborator

Shanghai First Maternity and Infant Hospital

OTHER

lead

Shanghai Gynecologic Oncology Group

OTHER_GOV