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

Last updated: March 27, 2025
Sponsor: Memorial Sloan Kettering Cancer Center
Overall Status: Active - Recruiting

Phase

2

Condition

Ovarian Cancer

Vaginal Cancer

Pelvic Cancer

Treatment

Second Look Laparoscopy

Clinical Study ID

NCT06240598
23-249
  • Ages > 18
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients assigned female at birth≥ 18 years of age

  • Suspected or known stage III-IV epithelial ovarian cancer for which the patient hasundergone, or is planned to undergo, attempted primary or interval debulking surgery

  • Homologous Recombination Deficiency testing should be planned to be completed priorto completion of initial platinum/taxane chemotherapy. HRD testing can be determinedusing :

  • Confirmation of deleterious Somatic or Germline BRCA mutation

  • CLIA certified test for HRD

  • Patients with a prior or concurrent malignancy whose natural history or treatmentdoes not have the potential to interfere with the safety or efficacy assessment ofthe investigational regimen are eligible for this trial

Exclusion

Exclusion Criteria:

  • Patients with the inability to swallow oral medications or impaired gastrointestinalabsorption due to gastrectomy or drainage gastrostomy tube

  • Patients receiving standard of care or investigational protocol directed treatmentare eligible for this study, with the exception of protocol directed treatment whichwould prohibit the SLL surgery from being performed

Study Design

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: Second Look Laparoscopy
Phase: 2
Study Start date:
January 26, 2024
Estimated Completion Date:
January 31, 2026

Connect with a study center

  • Johns Hopkins University (Data Collection Only)

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jersey 07920
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

    Middletown, New Jersey 07748
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey 07645
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Suffolk -Commack (Limited Protocol Activities)

    Commack, New York 11725
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New York 10604
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

    Uniondale, New York 11553
    United States

    Active - Recruiting

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