Cytoreduction With or Without Intraoperative Intraperitoneal Hyperthermic Chemotherapy (HIPEC) in Patients With Peritoneal Carcinomatosis From Ovarian Cancer, Fallopian Tube or Primary Peritoneal Carcinoma

Study Overview
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Brief Summary
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The purpose of this clinical trial is to Investigate whether the administration of HIPEC with Cisplatin (75 milligrams per square meter of body surface) after surgical cytoreduction in women with ovarian, tubal or primary peritoneal carcinoma increased disease-free survival period compared with patients without HIPEC treatment.

Official Title
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Cytoreduction With or Without Intraoperative Intraperitoneal Hyperthermic Chemotherapy (HIPEC) in Patients With Peritoneal Carcinomatosis From Ovarian Cancer, Fallopian Tube or Primary Peritoneal Carcinoma : Randomized Clinical Trial.

Conditions
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Peritoneal Carcinomatosis From Ovarian Cancer, Fallopian Tube Carcinoma, Primary Peritoneal Carcinoma

Intervention / Treatment
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* Procedure: Cytoreduction
* Drug: Hipec with Cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Peritoneal carcinomatosis arising from ovarian epithelial carcinoma (stage III or higher), carcinoma of the fallopian tube and primary peritoneal carcinoma. Residual tumor < 2.5 mm after completion of cytoreductive surgery. Aged < 75 years. Baseline ECOG 0-1 (Eastern Cooperative Oncologic Group). Adequate bone marrow function with hemoglobin ? 8 g/dl (after correction for iron deficiency anemia), white blood cell count ? 3,000/mm3, platelets ? 100,000/mm3. Adequate renal function with creatinine ? 1.5 mg/ dl. Adequate liver function with bilirubin levels ? 1.5 mg / dl and AST and ALT ? 80 IU / L. Optimal cardiopulmonary function. In recurrences, disease-free interval > 6 months. Voluntary and signed written informed consent. Exclusion Criteria: Extraperitoneal tumor disease. Suboptimal debulking (residual tumor > 2.5 mm). Previous history of other malignancies (excluding skin) Intestinal obstruction at the time of evaluation. Renal failure. Heart failure. Uncontrolled infection. Pregnant or lactating patients. In recurrences, disease-free interval < 6 months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Comparator<br>Comparator | Procedure: Cytoreduction<br>* Cytoreduction<br>|
| Experimental: Experimental<br>Experimental | Procedure: Cytoreduction<br>* Cytoreduction<br>Drug: Hipec with Cisplatin<br>* Intraoperative Intraperitoneal Hyperthermic Chemotherapy (Hipec)+Cisplatin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease-free survival period | Every three months until recurrence of disease. | Every 3 months up to 30 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of overall survival. | Every three months until recurrence of disease. | Every 3 months up to 30 months | 
| Study of morbidity. | Every three months until recurrence of disease. | Every 3 months up to 30 months | 
| Evaluation of quality of life related to the procedure. | Every three months until recurrence of disease. | Every 3 months up to 30 months | 
| Study of Ex vivo correlation. | in vitro cell culture to study the effect of temperature and cisplatin on cell viability | 4 days post surgery |