Laparoscopic Interval Cytoreductive Surgery in Advance Ovarian Cancer

March 24, 2025 updated by: David Isla Ortiz, Instituto Nacional de Cancerologia de Mexico

Efficiency of Laparoscopic Interval Cytoreductive Surgery After Neoadjuvant Chemotherapy in Patients With Stage III and IV Epithelial Ovarian Cancer

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Mexico
    • Tlalpan
      • México City, Tlalpan, Mexico, 14080
        • Recruiting
        • Instituto Nacional de Cancerologia
        • Contact:
        • Contact:
        • Principal Investigator:
          • David Isla Ortiz, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Procedure: Interval Cytoreduction Surgery

The procedure started with the cytoreduction of highest complexity (determined at the time of initial inspection), after which, if necessary, the patient underwent a complete hysterectomy, bilateral salpingo-oophorectomy, omentectomy, or partial peritonectomy and excision of any peritoneal implants present. The magnitude of the surgical procedures will be classified as:

  1. Standard surgery: minimal hysterectomy, adnexectomy y omentectomy
  2. Radical Surgery: included resection of the ovaries, of the rectouterine excavation (pouch of Douglas) and or the peritoneum between the bladder and uterus, hysterectomy, rectosigmoid colectomy, and complete omentectomy
  3. Supra-radical Surgery: included other procedures such as splenectomy, diaphragm resection, or other intestinal resection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Cancerologia de Mexico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2022

Primary Completion (Actual)

June 14, 2024

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

January 23, 2025

First Submitted That Met QC Criteria

March 12, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 26, 2025

Last Update Submitted That Met QC Criteria

March 24, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCAN MEXICO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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