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.
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.
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.
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.
Study summary
Optimal Timing of Surgery combined with Maintenance Therapy in the Front-line Treatment of Advanced Ovarian Cancer
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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:
1. white blood cells \>3,000/µL, absolute neutrophil count ≥1,500/µL, platelets ≥100,000/µL, hemoglobin ≥9 g/dL,
2. 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,
3. 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 Criteria:
* 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.
Primary outcome measure(s)
3-year overall survival — Participants will be followed for at least 3 years after randomization The proportion of patients alive at 3 years after entry into the study
Trial sites (9)
Facility
City
Region
Status
The First People's Hospital of Foshan
Foshan
China
Recruiting
Sun Yet-Sen University Cancer Center
Guangzhou
China
Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou
China
Recruiting
Zhejiang Cancer Hospital
Hangzhou
China
Recruiting
The First Affiliated Hospital of University of Science and Technology of China
Hefei
China
Recruiting
Fudan University Cancer Hospital
Shanghai
China
Recruiting
Obstetrics and Gynecology Hospital of Fundan University
Shanghai
China
Recruiting
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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