Role of Intraperitoneal Intraoperative Chemotherapy With Paclitaxel in the Surgical Treatment of Peritoneal Carcinomatosis From Ovarian Cancer. Hyperthermia Versus Normothermia

July 4, 2017 updated by: Sebastián Rufián, Maimónides Biomedical Research Institute of Córdoba
A randomized controlled single-blind clinical trial was performed, in 32 patients diagnosed with peritoneal carcinomatosis from epithelial ovarian cancer, who underwent radical surgery-peritonectomy, achieving an optimal R0-R1 cytoreduction (microscopic tumor residues (R0) or macroscopic tumor residues < 1cm (R1)) followed by hyperthermia against normothermia intraperitoneal intraoperative chemotherapy with paclitaxel

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 2

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:

  1. age ranged between 18 and 75 years old;
  2. histopathologic confirmation of peritoneal carcinomatosis from epithelial ovarian cancer (stage IIIc- FIGO (International Federation of Gynecology and Obstetrics));
  3. Karnofsky index > 70 or performance status ≤2;
  4. informed consent form filled out correctly.

Exclusion Criteria:

  1. unfulfillment of inclusion criteria;
  2. extraabdominal metastasis or stage IV FIGO (liver, lung, bone, etc);
  3. concomitance of another malignant neoplasm;
  4. renal, hepatic or cardiovascular dysfunction;
  5. intolerance during the treatment; - (6) refusal to participate in the study.

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: normothermic (36-37ºC)
Group 1, n=16(normothermic): Intraperitoneal administration of 60 mg/m2 paclitaxel per 2 liters of 1.5% dextrose in room temperature (36-37ºC).
Drug: Paclitaxel
Procedure: Radical surgery-peritonectomy
EXPERIMENTAL: hyperthermic (41-42ºC)
Group 2, n=16 (hyperthermic): Intraperitoneal administration of 60 mg/m2 paclitaxel per 2 liters of 1.5% dextrose in continuous hyperthermic perfusion (41-42ºC).
Drug: Paclitaxel
Procedure: Radical surgery-peritonectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Grouped Miller and Payne (MP) System for Pathological Response: G1 (Minimal Changes and < 30% Cells Tumour Reduction That Includes MP G1-G2), G3 (Microscopic Foci, Cells Tumour Reduction up to >90% That Includes MP G3-G4) and G5 (no Residual Tumour)
Time Frame: The biopsies were taken before and after the treatment (intraperitoneal intraoperative chemotherapy for 60 minutes) and then they were analysed by two blinded pathologists.
Histopathology scoring system to assess response, previous and post intraperitoneal intraoperative chemotherapy. Compare cancer cellularity of the biopsy (before treatment) with the other biopsy (after treatment).
The biopsies were taken before and after the treatment (intraperitoneal intraoperative chemotherapy for 60 minutes) and then they were analysed by two blinded pathologists.

Collaborators and Investigators

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

Sponsor

Maimónides Biomedical Research Institute of Córdoba

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)

July 1, 2012

Primary Completion (ACTUAL)

November 1, 2014

Study Completion (ACTUAL)

March 1, 2017

Study Registration Dates

First Submitted

April 4, 2016

First Submitted That Met QC Criteria

April 11, 2016

First Posted (ESTIMATE)

April 15, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 1, 2017

Last Update Submitted That Met QC Criteria

July 4, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI 0678-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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