Efficiency of Laparoscopic Interval Cytoreductive Surgery After Neoadjuvant Chemotherapy in Patients With Stage III and IV Epithelial Ovarian Cancer
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This is a study that aims to demonstrate the non-inferiority of minimally invasive surgery versus open surgery, as an approach for patients with advanced ovarian cancer who received neoadjuvant chemotherapy, giving them the benefits of laparoscopic surgery. This way they can continue with their complementary treatment.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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).
Locations
Other Locations
Mexico
Instituto Nacional de Cancerologia
RECRUITING
México
Contact Information
Primary
David Isla Ortiz, MD, M. Cs.
islasurgery@hotmail.com
+52 55 1850 9654
Time Frame
Start Date: 2022-05-19
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 33
Treatments
Experimental: Patients with advance ovarian cancer already treated with NACT and eligible for MIS
Were enrolled patients who met the inclusion criteria by receiving 3 to 4 cycles of NACT, with ca 125 up to 200 U/ml, and partial or complete response by image (PET-CT), and subsequently underwent laparoscopic approach.
Related Therapeutic Areas
Sponsors
Leads: Instituto Nacional de Cancerologia de Mexico