Cytoreduction With or Without Intraoperative Intraperitoneal Hyperthermic Chemotherapy (HIPEC) in… (NCT02328716) | Clinical Trial Compass
UnknownPhase 3
Cytoreduction With or Without Intraoperative Intraperitoneal Hyperthermic Chemotherapy (HIPEC) in Patients With Peritoneal Carcinomatosis From Ovarian Cancer, Fallopian Tube or Primary Peritoneal Carcinoma
Spain32 participantsStarted 2012-02
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexFEMALE
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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.
What they're measuring
1
disease-free survival period
Timeframe: Every 3 months up to 30 months
Trial details
NCT IDNCT02328716
SponsorFundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia