Overview

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

Status:
Not yet recruiting
Trial end date:
2027-02-01
Target enrollment:
0
Participant gender:
Female
Summary
Optimal Timing of Surgery combined with Maintenance Therapy in the Front-line Treatment of Advanced Ovarian Cancer
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Shanghai Gynecologic Oncology Group
Collaborator:
Fudan University
Treatments:
Niraparib
Poly(ADP-ribose) Polymerase Inhibitors
Criteria
Inclusion Criteria:

- Females aged ≥ 18 years.

- Pathologic confirmed stage IIIC and IV epithelial ovarian cancer, fallopian tube
cancer or primary peritoneal carcinoma

- Middle tumor burden and high tumor burden with cPCI score ≤ 12 based on pre-operative
PET/CT examination

- Complete cytoreduction can be achieved based on PET/CT examination

- Patients must agree to undergo BRCA (breast cancer gene) and HRD (homologous
recombination deficiency) testing

- Performance status (ECOG 0-2)

- Good ASA score (1/2)

- 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 niraparib or its excipients

- Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
or breast carcinoma (without any signs of relapse or activity).

- Any other concurrent medical conditions contraindicating surgery or chemotherapy that
could compromise the adherence to the protocol.

- Other conditions, such as religious, psychological and other factors, that could
interfere with provision of informed consent, compliance to study procedures, or
follow-up.