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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06240598
Other study ID # 23-249
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date January 26, 2024
Est. completion date January 2026

Study information

Verified date April 2024
Source Memorial Sloan Kettering Cancer Center
Contact Rachel Grisham, MD
Phone 646-888-4653
Email grishamr@mskcc.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date January 2026
Est. primary completion date January 2026
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Intervention

Procedure:
Second Look Laparoscopy
Second Look Laparoscopy (SLL)

Locations

Country Name City State
United States Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) Basking Ridge New Jersey
United States Memorial Sloan Kettering Suffolk -Commack (Limited Protocol Activities) Commack New York
United States Memorial Sloan Kettering Westchester (Limited Protocol Activities) Harrison New York
United States Memorial Sloan Kettering Monmouth (Limited Protocol Activities) Middletown New Jersey
United States Memorial Sloan Kettering Bergen (Limited Protocol Activities) Montvale New Jersey
United States Memorial Sloan Kettering Cancer Center New York New York
United States Memorial Sloan Kettering Nassau (Limited Protocol Activities) Uniondale New York

Sponsors (1)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary minimal residual disease (MRD) status will be based on surgicopathological findings from multiple biopsies and peritoneal cytology obtained during the SLL procedure up to 12 weeks
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