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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01376752
Recruitment Status : Recruiting
First Posted : June 20, 2011
Last Update Posted : November 1, 2017
Information provided by (Responsible Party):

Brief Summary:
CHIPOR hypothesis is that the adjunction of platinum HIPEC in first relapsed epithelial ovarian cancer is able to improve the median 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.

Condition or disease Intervention/treatment Phase
Ovarian Epithelial Cancer Recurrent Procedure: maximal cytoreductive surgery Phase 3

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  (Clinical Trial)
Estimated Enrollment : 444 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Randomized Study of Phase III Evaluating Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) in the Treatment of Relapse Ovarian Cancer
Study Start Date : April 2011
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Active Comparator: maximal cytoreductive surgery without HIPEC Procedure: maximal cytoreductive surgery
maximal cytoreductive surgery with or without HIPEC For HIPEC : the cisplatin will be used at 75mg/m2

Experimental: maximal cytoreductive surgery with HIPEC Procedure: maximal cytoreductive surgery
maximal cytoreductive surgery with or without HIPEC For HIPEC : the cisplatin will be used at 75mg/m2

Primary Outcome Measures :
  1. overall survival [ Time Frame: from randomization to death (up to 4 years) ]
    There is a follow-up period of 4 years.

Secondary Outcome Measures :
  1. relapse free survival [ Time Frame: from randomization to relapse (up to 4 years) ]
    There is a follow-up period of 4 years.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient age ≥ 18 yrs,
  • Performance Status OMS < 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 et ALAT ≤ 3 time the Upper Normal Limit,
  • No Renal insufficiency (serum creatinine < 1,5 time the normal limit, creatinine clearance >60 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01376752

Contact: Trevor Stanbury +33 1 44 23 55 67

Institut Jules Bordet Recruiting
Brussels, Belgium
Principal Investigator: Gabriel LIBERALE         
CHU d'AMIENS Recruiting
Amiens, France
Principal Investigator: Sophie SANGUIN         
Centre Paul Papin Recruiting
Angers Cedex 9, France, 49933
Contact: Gérard LORIMIER, Doctor   
Principal Investigator: Romuald WERNERT         
Centre Hospitaleir Universitaire Jean Minjoz Not yet recruiting
Besancon, France, 25000
Contact: Elsa KALBACHER, Dr   
Principal Investigator: Elsa KALBACHER         
Institut Bergonie Recruiting
Bordeaux Cedex, France, 33076
Contact: Frédéric GUYON, Doctor   
Principal Investigator: Frédéric GUYON         
Centre Francois Baclesse Not yet recruiting
Caen Cedex 3, France, 14076
Contact: Jean-Marc GUILLOIT, Doctor   
Principal Investigator: Jean-Marc GUILLOIT         
Centre Jean Perrin Recruiting
Clermont-ferrand Cedex 1, France, 63011
Contact: Christian POMEL, Pr   
Principal Investigator: Christian POMEL         
Centre hospitalier de Dijon Recruiting
Dijon, France
Principal Investigator: Jean-Marc ROUSSELET         
CHU Grenoble Not yet recruiting
Grenoble, France, 38043
Contact: Fabien PETITPERRIN   
Principal Investigator: Fabien PETITPERRIN         
CHU de Grenoble Recruiting
Grenoble, France
Principal Investigator: Cristina COSTAN         
Centre Oscar Lambret Recruiting
Lille, France, 59020
Contact: Eric LEBLANC, Dr   
Principal Investigator: Eric LEBLANC         
Centre Hospitalier Universitaire Dupuytren Recruiting
Limoges, France, 87042
Contact: Sylvaine DURAND-FONTANIER, Doctor   
Principal Investigator: Sylvaine DURAND-FONTANIER         
Centre Leon Berard Recruiting
Lyon Cedex 08, France, 69373
Contact: Pierre MEEUS, Doctor   
Principal Investigator: Pierre MEEUS         
Institut Paoli Calmettes Recruiting
Marseille Cedex 9, France, 13273
Contact: Gilles HOUVENAEGHEL, Pr   
Principal Investigator: Gilles HOUVENAEGHEL         
AP-HM - Hôpital de la Timone Recruiting
Marseille, France
Principal Investigator: Aubert AGOSTINI         
CRLC Val d'Aurelle Recruiting
Montpellier, France, 34298
Contact: François QUENET   
Principal Investigator: François QUENET         
Centre Hospitalier Universitaire Nice - Hopital L'Archet 2 Not yet recruiting
Nice Cedex 3, France, 06202
Contact: Jean-Marc BEREDER, Dr   
Principal Investigator: Jean-Marc BEREDER         
Hopital Lariboisiere Not yet recruiting
Paris, France, 75010
Contact: Marc POCARD   
Principal Investigator: Marc POCARD         
Hopital Tenon Not yet recruiting
Paris, France, 75020
Contact: Valeria LOI, Dr   
Principal Investigator: Valeria LOI         
Hôpital Européen Georges Pompidou Recruiting
Paris, France
Principal Investigator: Fabrice LECURU         
Institut Curie Recruiting
Paris, France
Principal Investigator: Pascale MARIANI         
Institute Curie Recruiting
Paris, France
Contact: Bernard BARANGER   
Principal Investigator: Bernard BARANGER         
Centre Hopsitalier Lyon Sud Recruiting
Pierre-benite Cedex, France, 69495
Contact: Olivier GLEHEN, Professor   
Principal Investigator: Olivier GLEHEN         
CHU - Hôpital de la Milétrie Recruiting
Poitiers, France
Principal Investigator: Cédric NADEAU         
Centre Jean Godinot Not yet recruiting
Reims Cedex, France, 51056
Contact: David KERE, Dr   
Principal Investigator: David KERE         
Centre Hospitalier Universitaire Saint Etienne- Hopital Nord Not yet recruiting
Saint-etienne, France, 42055
Contact: Karine ABBOUD, Dr   
Principal Investigator: Karine ABBOUD         
Ico-Centre Rene Gauducheau Recruiting
Saint-herblain Cedex, France, 44805
Contact: Jean-Marc CLASSE, Professor   
Principal Investigator: Jean-Marc CLASSE         
CHU Hautepierre Not yet recruiting
Strasbourg, France, 67098
Contact: Cécile BRIGAND   
Principal Investigator: Cécile BRIGAND         
Institut Claudius Regaud Recruiting
Toulouse Cedex, France, 31052
Contact: Gwenaël FERRON, Doctor   
Principal Investigator: Gwenaël FERRON         
Centre Alexis Vautrin Recruiting
Vandoeuvre-les-nancy Cedex, France, 54511
Contact: Frédéric MARCHAL, Pr   
Principal Investigator: Frédéric MARCHAL         
Institut Gustave Roussy Recruiting
Villejuif, France, 94805
Contact: Sébastien GOUY, Doctor   
Principal Investigator: Sébastien GOUY         
Hospital Universitari Germans Trias I Pujol Recruiting
Badalona, Spain
Principal Investigator: Juan José TORRENT         
Sponsors and Collaborators
Principal Investigator: Jean-Marc CLASSE Centre rené Gauducheau, NANTES

Responsible Party: UNICANCER Identifier: NCT01376752     History of Changes
Other Study ID Numbers: FEDEGYN 02 / 0410-CHIPOR
2010-023035-42 ( EudraCT Number )
First Posted: June 20, 2011    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Body Temperature Changes
Signs and Symptoms