Laparoscopic Interval Cytoreductive Surgery in Advance Ovarian Cancer

NCT06883409 | Recruiting

• 1 other identifier: INCAN MEXICO
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Neoplasms

Keywords

Minimal invasive surgery; interval debulking surgery; advance ovarian cancer

Outcome Measures

Primary Outcomes (1)

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

  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

Study Arms (1)

Patients with advance ovarian cancer already treated with NACT and eligible for MIS

EXPERIMENTAL

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

Interventions

Interval Cytoreduction Surgery PROCEDURE

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.

Patients with advance ovarian cancer already treated with NACT and eligible for MIS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Instituto Nacional de Cancerologia de Mexico: lead

Study Sites (1)

Instituto Nacional de Cancerologia

México, Tlalpan, 14080, Mexico

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Central Study Contacts

David Isla Ortiz, MD, M. Cs.

CONTACT

+52 55 1850 9654; islasurgery@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Gynecological Oncology

Model Details: A prospective single-arm phase II clinical trial study was conducted. We evaluated the efficacy and complications of interval laparoscopic cytoreduction in patients with COEA after NCT. Patients diagnosed with advanced ovarian carcinoma who received 3 to 4 cycles of NCT using carboplatin/paclitaxel with or without bevacizumab were included. Interval cytoreductive laparoscopic surgery was performed.

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: March 19, 2025
• Study Start: May 19, 2022
• Primary Completion: June 14, 2024
• Study Completion: December 30, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Locations

ME (1)