Evaluating Second Look Laparoscopy in Advanced Ovarian Cancer After Chemotherapy
Identification of Markers of Resistance During Frontline Therapy and Maintenance
This study is testing whether a second look surgery after chemotherapy can help people with advanced ovarian cancer who have little or no remaining disease feel better and improve their treatment outcomes.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT06240598 on ClinicalTrials.gov |
What this trial studies
This study investigates the health outcomes of individuals with advanced ovarian cancer who undergo a second look laparoscopy (SLL) following their initial chemotherapy treatment. It aims to compare outcomes between patients with minimal residual disease (MRD) and those without MRD at the time of SLL. The research will also assess the safety and feasibility of performing SLL in this patient population. By analyzing these factors, the study seeks to provide insights into the effectiveness of SLL in managing advanced ovarian cancer.
Who should consider this trial
Good fit: Ideal candidates are individuals assigned female at birth, aged 18 and older, with suspected or confirmed stage III-IV epithelial ovarian cancer who have completed their first course of chemotherapy.
Not a fit: Patients who are unable to swallow oral medications or have gastrointestinal absorption issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment strategies and outcomes for patients with advanced ovarian cancer.
How similar studies have performed: Previous studies have explored similar interventions, but the specific application of SLL in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Basking Ridge, New Jersey and 6 other locations
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Suffolk -Commack (Limited Protocol Activities) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York, United States (Recruiting)
Study contacts
- Principal investigator: Rachel Grisham, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Rachel Grisham, MD
- Email: grishamr@mskcc.org
- Phone: 646-888-4653
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.