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Second Look Laparoscopy for Disease Evaluation in Patients Who Have Completed Initial Chemotherapy for Advanced Ovarian Cancer
Trial Status: active
This clinical trial tests the safety, feasibility, and outcomes of undergoing a second look laparoscopy (SLL) for disease status evaluation after initial chemotherapy in patients with ovarian cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). SLL is a type of surgery that uses a laparoscope to look inside the abdomen without making a large incision. SLL can remove tissue to be checked for minimal residual disease (small amounts of cancer cells in the body after a person receives treatment). SLL may provide more information on disease status and outcomes in patients who have completed initial chemotherapy for advanced ovarian cancer.
Inclusion Criteria
Patients assigned female at birth ≥ 18 years of age
Suspected or known stage III-IV epithelial ovarian cancer for which the patient has undergone, or is planned to undergo, attempted primary or interval debulking surgery
Homologous recombination deficiency testing should be planned to be completed prior to completion of initial platinum/taxane chemotherapy. HRD testing can be determined using:
* Confirmation of deleterious somatic or germline BRCA mutation
* Clinical Laboratory Improvement Act (CLIA) certified test for HRD
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
Exclusion Criteria
Patients with the inability to swallow oral medications or impaired gastrointestinal absorption due to gastrectomy or drainage gastrostomy tube
Patients receiving standard of care or investigational protocol directed treatment are eligible for this study, with the exception of protocol directed treatment which would prohibit the SLL surgery from being performed
Additional locations may be listed on ClinicalTrials.gov for NCT06240598.
I. To evaluate the safety and feasibility of SLL in patients completing first-line therapy for advanced ovarian cancer.
SECONDARY OBJECTIVES:
I. To describe the progression free survival (PFS) and PFS at 12 months (PFS 12) for patients with homologous recombination deficient (HRD) or homologous recombination proficient (HRP) ovarian cancer and minimal residual disease (MRD) determined at time of SLL versus (vs) no MRD determined at time of SLL, treated in the front-line/maintenance.
II. To describe overall survival for all patients and for patients with or without MRD identified at time of SLL.
EXPLORATORY OBJECTIVES:
I. Development of organoids, generated from biopsies performed at progression of disease, to inform future planned interventional arms for those patients with resistant disease.
II. Association of MRD detected by SLL with other detection methods including ca-125 levels and circulating cell-free deoxyribonucleic acid (cfDNA) levels, and their association with PFS/overall survival (OS).
III. Description of PFS and OS for Longitudinal and Safety Analysis Dataset patient populations.
OUTLINE:
Within 12 weeks of completion of initial standard of care chemotherapy, patients undergo second look laparoscopy with biopsy. Patients then receive standard of care maintenance therapy or observation per their treating physician. Patients also undergo blood sample collection throughout the study and undergo computed tomography (CT) on study and during follow up.
After completion of the study intervention, patients are followed up every 3 months for the first 24 months, every 6 months for the next 36 months and then yearly thereafter.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationMemorial Sloan Kettering Cancer Center
