Laparoscopic Interval Cytoreductive Surgery in Advance Ovarian Cancer
NCT ID: NCT06883409
Last Updated: 2025-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
33 participants
INTERVENTIONAL
2022-05-19
2025-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Patients with advance ovarian cancer already treated with NACT and eligible for MIS
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.
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 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.
Interventions
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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 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
80 Years
FEMALE
No
Sponsors
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Instituto Nacional de Cancerologia de Mexico
OTHER
Responsible Party
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David Isla Ortiz
Head of Department of Gynecological Oncology
Locations
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Instituto Nacional de Cancerologia
México, Tlalpan, Mexico
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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INCAN MEXICO
Identifier Type: -
Identifier Source: org_study_id
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