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

Shanghai Gynecologic Oncology Group

Status and phase: Enrolling; Phase 2

Conditions: Primary Peritoneal Carcinoma; Fallopian Tube Cancer; Ovarian Cancer

Treatments: Drug: PARP inhibitor; Drug: Bevacizumab; Procedure: Neoadjuvant chemotherapy; Procedure: Primary debulking surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT05200260

SAT-1

Details and patient eligibility

About

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

Full 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 primarily diagnosed advanced epithelial ovarian cancer, fallopian tube cancer and primary peritoneal carcinoma.

Enrollment: 220 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

Upfront cytoreductive surgery with maintenance therapy

Experimental group

Description:

Primary debulking surgery with a maximal cytoreduction of complete gross resection within 3 weeks after biopsy, followed by at least 6 cycles of adjuvant chemotherapy and maintenance therapy for patients with CR/PR after platinum-based therapy (patients with or without BRCA mutation will be maintained by PARPi or Bevacizumab respectively ).

Treatment:

Procedure: Primary debulking surgery

Drug: Bevacizumab

Drug: PARP inhibitor

Neoadjuvant chemotherapy with maintenance therapy

Active Comparator group

Description:

Neoadjuvant chemotherapy with 3 cycles of chemotherapy, then followed by interval debulking surgery. The maximal time interval between course 3 chemotherapy and IDS is 6 weeks. And then 3 cycles of adjuvant chemotherapy and maintenance therapy for patients with CR/PR after platinum-based therapy (patients with or without BRCA mutation will be maintained by PARPi or Bevacizumab respectively ).

Treatment:

Procedure: Neoadjuvant chemotherapy

Drug: Bevacizumab

Drug: PARP inhibitor