Hyperthermic Intraperitoneal Chemotherapy (HIPEC) : Predictive Marker and Mechanism

August 30, 2019 updated by: Centre Hospitalier Universitaire de Nice

HSP90 as a Predictive Marker of the Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the Treatment of Peritoneal Carcinomatosis From Ovarian Origin.

Peritoneal carcinomatosis (PC) is the stage III of the FIGO ovarian cancer staging. It corresponds to an advanced stage with a relative 5 year survival rate of 52%. The multimodal treatment approach combines neoadjuvant chemotherapy, cytoreductive surgery of macroscopic lesions, and hyperthermic intraperitoneal chemotherapy (HIPEC). It has significantly improved survival rate in patients with ovarian PC and decreased recurrence and mortality rate by 21%. The efficacy of HIPEC is based on chemotherapy potentiated by the hyperthermia (43°). However, the cellular mechanisms involved are not fully understood, but they include cell death pathways and heat shock proteins (Hsp70 and Hsp90). RICCI et al. showed, based on pre-clinical models, that the efficacy of HIPEC was partly due to the overexpression and exposure of HSP90 on the cell surface leaded to an anti-cancer immune response. The aims of this study are to validate these findings in tissue samples of patients with ovarian PC. We will constitute a bank of isolated tumor samples before and after HIPEC and measure postoperative HSP90 serum levels in order to establish if they are predictive of a response. HSPs expression on the cancer cell surface will be determined by flow cytometry. Forty-four patients will be included. Elucidating the underlying mechanisms of HIPEC will broaden therapeutic possibilities including the use of new immunotherapy. The multimodal approach could improve the efficacy of HIPEC with a minimal systemic toxicity.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

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

  • France
      • Nice, France, 06000
        • Digestive department - Archet hospital

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Females over 18 years.
  • Indication of Hyperthermic Intra Peritoneal Chemotherapy (HIPEC) for peritoneal carcinomatosis from ovarian origin
  • Obtaining written informed consent and signed for participation in the study and conservation of samples taken.
  • Affiliation to a social security scheme.

Non-inclusion criteria

  • Major patients protected by law or deprived of liberty.
  • Patients pregnant women in labor or breastfeeding.
  • Refusal of participation
  • Another cause of peritoneal carcinomatosis

Exclusion Criteria:

  • consent withdrawn

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: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient with HIPEC
Biological: peripheral venous blood samples
peripheral venous blood samples measured preoperatively and postoperatively HIPEC (Day 1, day 3 and day 5 postoperative)
Sham Comparator: Patient without HIPEC
Biological: peripheral venous blood samples
peripheral venous blood samples measured preoperatively and postoperatively HIPEC (Day 1, day 3 and day 5 postoperative)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in serum levels of HSP90 and 70 on peripheral venous samples.
Time Frame: basal levels (preoperatively), postoperatively HIPEC (Day 1, day 3 and day 5 postoperative)
Changes in serum levels of HSP90 and 70 postoperatively HIPEC (Day 1, day 3 and day 5 postoperative) compared to basal levels measured preoperatively on peripheral venous samples. Patients who had HIPEC will be compared with patients overturned on early intervention
basal levels (preoperatively), postoperatively HIPEC (Day 1, day 3 and day 5 postoperative)

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

  • Principal Investigator: Jean-Marc BEREDER, MD, Centre Hospitalier Universitaire de Nice

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)

January 16, 2017

Primary Completion (Actual)

July 2, 2017

Study Completion (Actual)

July 2, 2017

Study Registration Dates

First Submitted

June 14, 2016

First Submitted That Met QC Criteria

June 14, 2016

First Posted (Estimate)

June 17, 2016

Study Record Updates

Last Update Posted (Actual)

September 4, 2019

Last Update Submitted That Met QC Criteria

August 30, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-AOI-11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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