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

December 12, 2017 updated by: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Murcia
      • El Palmar., Murcia, Spain, 30120
        • Recruiting
        • Hospital Clinico Universitario Virgen de la Arrixaca
        • Contact:
          • Pedro Cascales Campos
          • Phone Number: 968369500
        • Principal Investigator:
          • Pedro Cascales Campos, M.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Comparator
Procedure: Cytoreduction
Cytoreduction
EXPERIMENTAL: Experimental
Procedure: Cytoreduction
Cytoreduction
Drug: Hipec with Cisplatin
Intraoperative Intraperitoneal Hyperthermic Chemotherapy (Hipec)+Cisplatin

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Investigators

  • Study Director: Pedro Cascales Campos, M.D Phd, Hospital Universitario Virgen de La Arrixaca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2012

Primary Completion (ANTICIPATED)

December 1, 2018

Study Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

December 5, 2014

First Submitted That Met QC Criteria

December 29, 2014

First Posted (ESTIMATE)

December 31, 2014

Study Record Updates

Last Update Posted (ACTUAL)

December 13, 2017

Last Update Submitted That Met QC Criteria

December 12, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC-GC/AD-01/11
  • 2011-001715-31 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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