Surgery Combined With Maintenance Targeted Therapy in the Treatment of Advanced Ovarian Cancer

Launched by SHANGHAI GYNECOLOGIC ONCOLOGY GROUP · Jan 17, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring the best timing for surgery combined with targeted therapy for women with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal carcinoma. The goal is to see how effectively surgery and ongoing treatment can work together to improve outcomes for patients diagnosed with these conditions.

To participate in this study, women must be at least 18 years old and have been diagnosed with specific advanced stages of these cancers. Participants will need to have a certain level of tumor burden and be able to undergo surgery successfully. They will also be tested for specific genetic factors related to cancer. Throughout the trial, participants will receive treatment and regular check-ups to monitor their health. It's important for anyone considering joining the study to be aware that they need to provide informed consent and comply with the study guidelines.

Gender

FEMALE

Eligibility criteria

• 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.