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

Phase 3

• Conditions: Peritoneal Carcinomatosis From Ovarian Cancer; Fallopian Tube Carcinoma; Primary Peritoneal Carcinoma
• Interventions: Procedure: Cytoreduction; Drug: Hipec with Cisplatin

• Registration Number: NCT02328716
• Lead Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2014-12-05
• Study First Submitted QC: 2014-12-29
• Study First Posted: 2014-12-31
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-12
• Last Update Posted: 2017-12-13
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Cytoreduction	Experimental
Comparator	Cytoreduction	Comparator
Experimental	Hipec with Cisplatin	Experimental

Primary Outcome Measures

Name	Time	Method
disease-free survival period	Every 3 months up to 30 months	Every three months until recurrence of disease.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Clínico Universitario Virgen de la Arrixaca; 🇪🇸 El Palmar., Murcia, Spain