Status:
RECRUITING
Surgery Combined With Maintenance Targeted Therapy in the Treatment of Advanced Ovarian Cancer
Lead Sponsor:
Shanghai Gynecologic Oncology Group
Collaborating Sponsors:
Fudan University
Conditions:
Ovarian Cancer
Fallopian Tube Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
Optimal Timing of Surgery combined with Maintenance Therapy in the Front-line Treatment of Advanced Ovarian Cancer
Detailed 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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT05200260
Start Date
July 13 2022
End Date
June 1 2027
Last Update
February 10 2025
Active Locations (9)
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1
The First People's Hospital of Foshan
Foshan, China
2
Sun Yet-Sen University Cancer Center
Guangzhou, China
3
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China
4
Zhejiang Cancer Hospital
Hangzhou, China