Laparoscopic Interval Cytoreductive Surgery in Advance Ovarian Cancer

Instituto Nacional de Cancerologia de Mexico

Status: Enrolling

Conditions: Ovarian Neoplasms

Treatments: Procedure: Interval Cytoreduction Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT06883409

INCAN MEXICO

Details and patient eligibility

About

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.

Enrollment: 33 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

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

Experimental group

Description:

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.

Treatment:

Procedure: Interval Cytoreduction Surgery