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Recruiting NCT06883409

Laparoscopic Interval Cytoreductive Surgery in Advance Ovarian Cancer

No phase Interventional Ovarian Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Interval Cytoreduction Surgery.
Who it may be relevant to
Registry conditions: Ovarian Neoplasms. Basic parameters: 18 years — 80 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Mexico
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Efficiency of Laparoscopic Interval Cytoreductive Surgery After Neoadjuvant Chemotherapy in Patients with Stage III and IV Epithelial Ovarian Cancer [Time frame: 1 year]

Eligibility 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Mexico · 1 center
  • Instituto Nacional de Cancerologia — México

Identifiers

NCT: NCT06883409 · INCAN MEXICO

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗