Efficiency of Laparoscopic Interval Cytoreductive Surgery After Neoadjuvant Chemotherapy in Patients With Stage III and IV Epithelial Ovarian Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Efficiency of Laparoscopic Interval Cytoreductive Surgery After Neoadjuvant Chemotherapy in Patients with Stage III and IV Epithelial Ovarian Cancer
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
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.
Intervention: Interval Cytoreduction Surgery (Procedure)
Outcomes
Primary Outcomes
Efficiency of Laparoscopic Interval Cytoreductive Surgery After Neoadjuvant Chemotherapy in Patients with Stage III and IV Epithelial Ovarian Cancer
Time Frame: 1 year
Efficiency of laparoscopic interval surgery will be evaluated according to percentage of patients who achieved optimal cytoreduction compared to the reported rates in the literature (70 -80%) and the measured frequency of complications during the 30 day postoperative period. Severity of complications will be measured using the Clavien Dindo scale (Grade I: any deviation from the normal post operative course without need for pharmacological treatment - Grade V: death)
Secondary Outcomes
No secondary outcomes reported
Investigators
David Isla Ortiz
Head of Department of Gynecological Oncology
None in Three Research Centre