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

RecruitingPhase 2Ages 18 Years - anyFemaleShanghai Gynecologic Oncology Group
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In plain words

What the trial is, and whether it could suit you

Optimal Timing of Surgery combined with Maintenance Therapy in the Front-line Treatment of Advanced Ovarian Cancer

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Primary debulking surgery
  • Neoadjuvant chemotherapy
  • PARP inhibitor
  • Bevacizumab
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Where

9 sites
The First People's Hospital of Foshan
Foshan, China
Sun Yet-Sen University Cancer Center
Guangzhou, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China
Zhejiang Cancer Hospital
Hangzhou, China
The First Affiliated Hospital of University of Science and Technology of China
Hefei, China
Fudan University Cancer Hospital
Shanghai, China
Obstetrics and Gynecology Hospital of Fundan University
Shanghai, China
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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