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

Primary Peritoneal Carcinoma Clinical Trial

— CARCINOHIPEC  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02328716
• Other study ID #: EC-GC/AD-01/11
• Secondary ID: 2011-001715-31
• Status: Recruiting
• Phase: Phase 3
• First received: December 5, 2014
• Last updated: December 12, 2017
• Start date: February 2012
• Est. completion date: December 2018

Study information

• Verified date: December 2017
• Source: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
• Contact: Pedro Cascales Campos , MD ,PhD
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Fallopian Tube Carcinoma
• Fallopian Tube Neoplasms
• Fever
• Ovarian Neoplasms
• Peritoneal Carcinomatosis From Ovarian Cancer
• Primary Peritoneal Carcinoma

Intervention

Procedure:
• Cytoreduction
Cytoreduction

Drug:
• Hipec with Cisplatin
Intraoperative Intraperitoneal Hyperthermic Chemotherapy (Hipec)+Cisplatin

Locations

Country	Name	City	State
Spain	Hospital Clínico Universitario Virgen de la Arrixaca	El Palmar.	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

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