Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) in Relapse Ovarian Cancer Treatment (CHIPOR)

April 9, 2024 updated by: UNICANCER

A Phase III Randomized Study Evaluating Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) in the Treatment of Relapse Ovarian Cancer

CHIPOR hypothesis is that the adjunction of platinum HIPEC in first relapsed epithelial ovarian cancer is able to improve the median Overall Survival (OS) by 12 months. In that hypothesis, with alpha risk of 5%, a power beta of 80%, during a 3 years period of inclusion and a 3 years follow-up, the number of patients to include is 404. Taking into account a 10% failure, an overall number of 444 patients is required.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The patient received before the surgery a second line chemotherapy, platinum-based regimen with either carboplatine-paclitaxel, or carboplatine-caelyx. At the end of the six courses IV chemotherapy, if the disease is still responding and if a complete cytoreductive surgery seems possible, the patient is included after signed informed consent and will be operated 5 to 8 weeks after the last second-line chemotherapy cycle.

So, during the surgery the patient will be randomized if the complete cytoreductive surgery is really done and will then receive:

  • either treatment A = maximal cytoreductive surgery without HIPEC
  • or treatment B = maximal cytoreductive surgery with HIPEC

The HIPEC will be done at the end of the surgery. At the end of cytoreductive surgery, tumor residual disease must be null or very limited (Sugarbaker completeness cytoreduction: CC0 (no residual)-CC1 (residual < 0.25cm).

Two methods will be used for the HIPEC: Open or closed abdomen, depends on the site practice. Each site will use the same method during the study for all included patients.

Study Type

Interventional

Enrollment (Actual)

415

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

  • Belgium
      • Brussels, Belgium
        • Institut Jules Bordet
  • France
      • Amiens, France
        • CHU d'AMIENS
      • Angers, France, 49933
        • Centre Paul Papin
      • Bordeaux, France, 33076
        • Institut Bergonié
      • Brest, France
        • Clinique Pasteur
      • Brest, France
        • Polyclinique Kéraudren
      • Caen, France, 14076
        • Centre François Baclesse
      • Clermont-ferrand, France, 63011
        • Centre Jean Perrin
      • Dijon, France
        • Centre hospitalier de Dijon
      • Grenoble, France
        • CHU de Grenoble
      • Le Mans, France
        • Clinique Victor Hugo
      • Le Mans, France
        • Pôle Santé Sud
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Lille, France
        • CHU de Lille
      • Limoges, France, 87042
        • Centre Hospitalier Universitaire Dupuytren
      • Lyon, France, 69373
        • Centre Léon Bérard
      • Lyon, France, 69495
        • Centre Hopsitalier Lyon Sud
      • Marseille, France, 13273
        • Institut Paoli Calmettes
      • Marseille, France
        • AP-HM - Hôpital de la Timone
      • Montpellier, France, 34298
        • CRLC Val d'Aurelle
      • Nice, France, 06202
        • Centre Hospitalier Universitaire Nice
      • Paris, France, 75010
        • Hôpital Lariboisière
      • Paris, France, 75020
        • Hôpital Tenon
      • Paris, France
        • Hôpital Européen Georges Pompidou
      • Paris, France
        • Institut Curie
      • Poitiers, France
        • CHU - Hôpital de la Milétrie
      • Saint-etienne, France, 42055
        • Centre Hospitalier Universitaire Saint Etienne- Hopital Nord
      • Saint-herblain, France, 44805
        • Ico-Centre Rene Gauducheau
      • Strasbourg, France, 67098
        • CHU HautePierre
      • Toulouse, France, 31052
        • Institut Claudius Regaud
      • Vandoeuvre-les-nancy, France, 54511
        • Centre Alexis Vautrin
      • Villejuif, France, 94805
        • Institut Gustave Roussy
  • Spain
      • Badalona, Spain
        • Hospital Universitari Germans Trias i Pujol

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

Description

Inclusion Criteria:

  • Patient age ≥ 18 years
  • Performance Status WHO < 2
  • Initially treated for Epithelial Ovarian Carcinoma
  • Patient with only peritoneal relapse occurred at least 6 month from the initial treatment, resectable without distant metastasis (with the exception of communicating pleura effusion, sensitive to platine-based second line chemotherapy and resectable lymph-nodes in the groin or retro peritoneal)
  • Platinum based second-line chemotherapy before surgery with either carboplatine-paclitaxel, or carboplatine-caelyx
  • Complete cytoreductive surgery
  • The surgery has to be planned 5 to 8 weeks from the last 2nd of chemotherapy
  • No hepatic failure, bilirubin ≤ 1,5 time the Normal limit, ASAT and ALAT ≤ 3 time the Upper Normal Limit
  • No Renal insufficiency (serum creatinine < 1,5 time the normal limit, creatinine clearance > 80 mL/min). calculated with MDRD method
  • Hematology function: PNN ≥ 1,5x10⁹/L, platelets ≥ 100x10⁹/L
  • No contraindication to general anaesthesia for heavy surgery
  • Patients having read, signed and dated Informed consent before any study procedure
  • Childbearing patients have to take appropriate contraceptive methods during the treatment and until 6 months after the treatment

Exclusion Criteria:

  • Patient age <18 years
  • Previous cancer in the last 5 years (except cutaneous baso-cellular epithelioma or uterine peripheral epithelioma)
  • Hypersensitivity to Platinum compound
  • Distant metastasis
  • Use of anti-angiogenic treatment
  • Patient with other concurrent severe life threatening disease
  • The need to perform more than two segmental digestive resections during the CRS +/- HIPEC surgery
  • Any progressive disease during the IV systemic second-line chemotherapy (platine-based)
  • Incomplete cytoreductive surgery with macroscopical residual disease (Sugarbaker > CC1)
  • Early relapse: less than 6 mois after the end of the first treatment
  • Ovarian tumor other than Epithelioma Ovarian Cancer
  • Uncontrolled infection
  • Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  • Clinically significant cardiovascular disease contraindicating the hyper hydratation, which is necessary for HIPEC
  • Patient already treated with HIPEC for the ovarian cancer
  • Individual deprived of liberty or placed under the authority of a tutor

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: maximal cytoreductive surgery without HIPEC
The participant will have a regular cytoreductive surgery without the adjunction of HIPEC.
Procedure: Maximal cytoreductive surgery
Maximal cytoreductive surgery
Experimental: maximal cytoreductive surgery with HIPEC
The participant will have a regular cytoreductive surgery, then the adjunction of HIPEC: hyperthermic cisplatin will be used at 75mg/m²
Procedure: Maximal cytoreductive surgery
Maximal cytoreductive surgery
Drug: HIPEC
HIPEC: Hyperthermic Intra-PEritoneal Chemotherapy. Administration of cisplatin at 75mg/m²

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: from randomization to death (up to 4 years)
Follow-up of 4 years.
from randomization to death (up to 4 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
relapse free survival
Time Frame: from randomization to relapse (up to 4 years)
Follow-up of 4 years.
from randomization to relapse (up to 4 years)

Collaborators and Investigators

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

Sponsor

UNICANCER

Investigators

  • Principal Investigator: Jean-Marc CLASSE, Centre rené Gauducheau, NANTES

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)

April 26, 2011

Primary Completion (Actual)

January 8, 2023

Study Completion (Estimated)

May 14, 2025

Study Registration Dates

First Submitted

March 28, 2011

First Submitted That Met QC Criteria

June 17, 2011

First Posted (Estimated)

June 20, 2011

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FEDEGYN 02 / 0410-CHIPOR
  • 2010-023035-42 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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