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Surgery Combined With Maintenance Targeted Therapy in the Treatment of Advanced Ovarian Cancer
RECRUITINGPhase 2Sponsored by Shanghai Gynecologic Oncology Group
Actively Recruiting
PhasePhase 2
SponsorShanghai Gynecologic Oncology Group
Started2022-07-13
Est. completion2027-06
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05200260
Summary
Optimal Timing of Surgery combined with Maintenance Therapy in the Front-line Treatment of Advanced Ovarian Cancer
Eligibility
Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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.
Conditions4
CancerFallopian Tube CancerOvarian CancerPrimary Peritoneal Carcinoma
Interventions2
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Actively Recruiting
PhasePhase 2
SponsorShanghai Gynecologic Oncology Group
Started2022-07-13
Est. completion2027-06
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05200260