A Study of Second Look Laparoscopy (SLL) in People With Ovarian Cancer Who Have Completed Their First Course of Chemotherapy

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Description

The researchers are doing this study to look at the health outcomes of people with advanced ovarian cancer who have a second look laparoscopy (SLL) after they complete their first course of chemotherapy. The researchers will compare the health outcomes of people who have minimal residual disease (MRD-small amounts of cancer cells in the body after a person receives treatment) at the time of SLL with the health outcomes of people who do not have MRD at the time of SLL. The researchers are also doing this study to determine if SLL is safe and practical (feasible) in people with advanced ovarian cancer who have completed the first course of therapy for their disease.

Targeted Conditions

Study Overview

Start Date
January 26, 2024
Completion Date
January 1, 2026
Enrollment
80
Date Posted
February 5, 2024
Accepts Healthy Volunteers?
No
Gender
Female

Locations

Full Address
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey 07920, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey 07748, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey 07645, United States

Memorial Sloan Kettering Suffolk -Commack (Limited Protocol Activities)
Commack, New York 11725, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York 10604, United States

Memorial Sloan Kettering Cancer Center
New York, New York 10065, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York 11553, United States

Eligibility

Minimum Age (years)
18
Eligibility Criteria
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
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

Study Contact Info

Study Contact Name
Rachel Grisham, MD; Kara Long Roche, MD
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
NCTid (if applicable)
NCT06240598