Overview
Optimal Timing of Surgery combined with Maintenance Therapy in the Front-line Treatment of Advanced Ovarian Cancer
Description
The purpose of this trial is to answer the fundamental question 'The Optimal Timing of Surgery' combined with Bevacizumab or Poly-adenosine Ribose Phosphate Inhbitors (PARPi), in the circumstance of primarily diagnosed advanced epithelial ovarian cancer, fallopian tube cancer and primary peritoneal carcinoma.
Eligibility
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:
- 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 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.