This trial is active, not recruiting.

Conditions peritoneal carcinomatosis from ovarian cancer, fallopian tube carcinoma, primary peritoneal carcinoma
Treatments cytoreduction, hipec with cisplatin
Phase phase 3
Sponsor Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Start date February 2012
End date September 2014
Trial size 32 participants
Trial identifier NCT02328716, 2011-001715-31, EC-GC/AD-01/11


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
(Active Comparator)
hipec with cisplatin
Intraoperative Intraperitoneal Hyperthermic Chemotherapy (Hipec)+Cisplatin

Primary Outcomes

disease-free survival period
time frame: Every 3 months up to 30 months

Secondary Outcomes

Evaluation of overall survival.
time frame: Every 3 months up to 30 months
Study of morbidity.
time frame: Every 3 months up to 30 months
Evaluation of quality of life related to the procedure.
time frame: Every 3 months up to 30 months
Study of Ex vivo correlation.
time frame: 4 days post surgery

Eligibility Criteria

Female participants from 18 years up to 75 years old.

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.

Additional Information

Official title 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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia.