Minimally invasive surgery for advanced ovarian cancer
Efficiency of Laparoscopic Interval Cytoreductive Surgery After Neoadjuvant Chemotherapy in Patients With Stage III and IV Epithelial Ovarian Cancer
This study is testing if a less invasive surgery for advanced ovarian cancer can be just as effective as traditional surgery after patients have received chemotherapy, while also helping them recover faster and feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 33 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Instituto Nacional de Cancerologia de Mexico Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (México, Tlalpan) |
| Trial ID | NCT06883409 on ClinicalTrials.gov |
What this trial studies
This study aims to demonstrate that laparoscopic interval cytoreductive surgery is as effective as open surgery for patients with advanced ovarian cancer who have undergone neoadjuvant chemotherapy. By utilizing minimally invasive techniques, the study seeks to provide patients with the benefits of reduced recovery time and improved quality of life while continuing their complementary treatments. The approach involves evaluating patients' responses to chemotherapy through PET-CT imaging before proceeding with surgery.
Who should consider this trial
Good fit: Ideal candidates include women diagnosed with stage III-IV epithelial ovarian cancer who have shown a partial or complete response to neoadjuvant chemotherapy.
Not a fit: Patients with unresectable disease or those who have not responded adequately to chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and quality of life for patients with advanced ovarian cancer.
How similar studies have performed: Other studies have shown promising results with minimally invasive approaches in various cancers, suggesting potential success for this method in ovarian cancer as well.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of epithelial ovarian cancer (all subtypes of epithelial ovarian cancer) in stage III-IV * Partial and complete response to treatment with QTNA after 3-4 cycles, evaluated by PET-CT imaging study, patients that the functional unit decides to incorporate into the project. * Ca 125 which will have to be less than 200 * ECOG 0 to 2 without medical contraindication to perform surgery (≤ ASA 2 or ≤ Goldman 2). Exclusion Criteria: * Partial response with persistence of ascites or pleural effusion. * With unresectability criteria (multiple intrahepatic liver metastases, retroperitoneal lymph node conglomerates \>2cm above the renal lymph nodes, metastatic disease above the diaphragm, multiple intestinal involvement and mesentery retraction).
Where this trial is running
México, Tlalpan
- Instituto Nacional de Cancerologia — México, Tlalpan, Mexico (Recruiting)
Study contacts
- Study coordinator: David Isla Ortiz, MD, M. Cs.
- Email: islasurgery@hotmail.com
- Phone: +52 55 1850 9654
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.