Laparoscopic Interval Cytoreductive Surgery in Advance Ovarian Cancer

NCT06883409RecruitingNAINTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Instituto Nacional de Cancerologia de Mexico

Enrollment

33

Start Date

2022-05-19

Completion Date

2024-06-14

Study Type

INTERVENTIONAL

Official Title

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

Interventions

Interval Cytoreduction Surgery

Conditions

Ovarian Neoplasms

Eligibility

Age Range

18 Years – 80 Years

Sex

FEMALE

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).

Outcome Measures

Primary Outcomes

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)

Time frame: 1 year

Locations

Instituto Nacional de Cancerologia, México, Mexico