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

Inclusion Criteria12

Females aged ≥ 18 years.
Pathologic confirmed stage IIIC and IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma
Low, Middle tumor burden and high tumor burden with cPCI score ≤ 12 based on pre-operative CT or PET/CT examination
Complete cytoreduction can be achieved based on CT or PET/CT examination
Patients must agree to undergo BRCA (breast cancer gene) and HRD (homologous recombination deficiency) testing
Performance status (ECOG 0-2)
Adequate bone marrow, renal and hepatic function to receive chemotherapy and subsequent surgery:
white blood cells \>3,000/µL, absolute neutrophil count ≥1,500/µL, platelets ≥100,000/µL, hemoglobin ≥9 g/dL,
serum creatinine \<1.25 x upper normal limit (UNL) or creatinine clearance ≥60 mL/min according to Cockroft-Gault formula or to local lab measurement,
serum bilirubin \<1.25 x UNL, AST(SGOT) and ALT(SGPT) \<2.5 x UNL.
Comply with the study protocol and follow-up.
Patients who have given their written informed consent.

Exclusion Criteria8

Non-epithelial ovarian malignancies and borderline tumors
Low grade ovarian cancer
Mucinous ovarian cancer
Complete cytoreduction cannot be achieved according to preoperative evaluation, including pulmonary and hepatic parenchymal metastases, unresectable extensive pleural metastases, multiple thoracic lymph nodes metastases, brain or bone metastases
Patient has a known hypersensitivity to the components of olaparib/bevacizumab or its excipients
Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ, thyroid carcinoma, or breast carcinoma (without any signs of relapse or activity, early-stage).
Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise adherence to the protocol.
Other conditions, such as religious, psychological, and other factors, that could interfere with the provision of informed consent, compliance to study procedures, or follow-up.

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.