Ovarian Neoplasms
Conditions
Keywords
Minimal invasive surgery, interval debulking surgery, advance ovarian cancer
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.
Interventions
PROCEDUREInterval 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.
Sponsors
Instituto Nacional de Cancerologia de Mexico
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficiency of Laparoscopic Interval Cytoreductive Surgery After Neoadjuvant Chemotherapy in Patients with Stage III and IV Epithelial Ovarian Cancer | 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) |
Countries
Mexico
Contacts
Primary ContactDavid Isla Ortiz, MD, M. Cs.
Outcome results
None listed