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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by UNICANCER
Sponsor:
Information provided by (Responsible Party):
UNICANCER
ClinicalTrials.gov Identifier:
NCT01376752
First received: March 28, 2011
Last updated: December 6, 2012
Last verified: December 2012
  Purpose

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 Intervention Phase
Ovarian Epithelial Cancer Recurrent
Procedure: maximal cytoreductive surgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by UNICANCER:

Primary Outcome Measures:
  • overall survival [ Time Frame: from randomization to death (up to 4 years) ] [ Designated as safety issue: Yes ]
    There is a follow-up period of 4 years.


Secondary Outcome Measures:
  • relapse free survival [ Time Frame: from randomization to relapse (up to 4 years) ] [ Designated as safety issue: Yes ]
    There is a follow-up period of 4 years.


Estimated Enrollment: 444
Study Start Date: April 2011
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01376752

Contacts
Contact: Anne-Laure MARTIN +33 1 44 23 55 56 al-martin@fnclcc.fr

Locations
France
Centre Paul Papin Recruiting
Angers Cedex 9, France, 49933
Contact: Gérard LORIMIER, Doctor       g.lorimier@angers.fnclcc.fr   
Principal Investigator: Gérard LORIMIER         
Centre Hospitaleir Universitaire Jean Minjoz Not yet recruiting
Besancon, France, 25000
Contact: Elsa KALBACHER, Dr       ekalbacher@gmail.com   
Principal Investigator: Elsa KALBACHER         
Institut Bergonie Recruiting
Bordeaux Cedex, France, 33076
Contact: Frédéric GUYON, Doctor       guyon@bergonie.org   
Principal Investigator: Frédéric GUYON         
Centre Francois Baclesse Not yet recruiting
Caen Cedex 3, France, 14076
Contact: Jean-Marc GUILLOIT, Doctor       jm.guilloit@baclesse.fr   
Principal Investigator: Jean-Marc GUILLOIT         
Centre Jean Perrin Recruiting
Clermont-ferrand Cedex 1, France, 63011
Contact: Christian POMEL, Pr       Christophe.POMEL@cjp.fr   
Principal Investigator: Christian POMEL         
CHU Grenoble Not yet recruiting
Grenoble, France, 38043
Contact: Fabien PETITPERRIN       FPetitperrin@chu-grenoble.fr   
Principal Investigator: Fabien PETITPERRIN         
Centre Oscar Lambret Recruiting
Lille, France, 59020
Contact: Eric LEBLANC, Dr       e-leblanc@o-lambret.fr   
Principal Investigator: Eric LEBLANC         
Centre Hospitalier Universitaire Dupuytren Recruiting
Limoges, France, 87042
Contact: Sylvaine DURAND-FONTANIER, Doctor       sylvainedurand-fontanier@voila.fr   
Principal Investigator: Sylvaine DURAND-FONTANIER         
Centre Leon Berard Recruiting
Lyon Cedex 08, France, 69373
Contact: Pierre MEEUS, Doctor       MEEUS@lyon.fnclcc.fr   
Principal Investigator: Pierre MEEUS         
Institut Paoli Calmettes Recruiting
Marseille Cedex 9, France, 13273
Contact: Gilles HOUVENAEGHEL, Pr       houvenaeghelg@marseille.fnclcc.fr   
Principal Investigator: Gilles HOUVENAEGHEL         
CRLC Val d'Aurelle Recruiting
Montpellier, France, 34298
Contact: François QUENET       francois.quenet@montpellier.unicancer.fr   
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       ber224@chu-nice.fr   
Principal Investigator: Jean-Marc BEREDER         
Hopital Lariboisiere Not yet recruiting
Paris, France, 75010
Contact: Marc POCARD       marc.pocard@lrb.aphp.fr   
Principal Investigator: Marc POCARD         
Hopital Tenon Not yet recruiting
Paris, France, 75020
Contact: Valeria LOI, Dr       valeria.loi@tnn.aphp.fr   
Principal Investigator: Valeria LOI         
Institute Curie Recruiting
Paris, France
Contact: Bernard BARANGER       bernard.baranger@curie.net   
Principal Investigator: Bernard BARANGER         
Centre Hopsitalier Lyon Sud Recruiting
Pierre-benite Cedex, France, 69495
Contact: Olivier GLEHEN, Professor       olivier.glehen@chu-lyon.fr   
Principal Investigator: Olivier GLEHEN         
Centre Jean Godinot Not yet recruiting
Reims Cedex, France, 51056
Contact: David KERE, Dr       david.kere@reims.fnclcc.fr   
Principal Investigator: David KERE         
Centre Hospitalier Universitaire Saint Etienne- Hopital Nord Not yet recruiting
Saint-etienne, France, 42055
Contact: Karine ABBOUD, Dr       abboud_go@yahoo.fr   
Principal Investigator: Karine ABBOUD         
Ico-Centre Rene Gauducheau Recruiting
Saint-herblain Cedex, France, 44805
Contact: Jean-Marc CLASSE, Professor       jm-classe@nantes.fnclcc.fr   
Principal Investigator: Jean-Marc CLASSE         
CHU Hautepierre Not yet recruiting
Strasbourg, France, 67098
Contact: Cécile BRIGAND       cecile.brigand@chru-strasbourg.fr   
Principal Investigator: Cécile BRIGAND         
Institut Claudius Regaud Recruiting
Toulouse Cedex, France, 31052
Contact: Gwenaël FERRON, Doctor       ferron.gwenael@claudiusregaud.fr   
Principal Investigator: Gwenaël FERRON         
Centre Alexis Vautrin Recruiting
Vandoeuvre-les-nancy Cedex, France, 54511
Contact: Frédéric MARCHAL, Pr       f.marchal@nancy.fnclcc.fr   
Principal Investigator: Frédéric MARCHAL         
Institut Gustave Roussy Recruiting
Villejuif, France, 94805
Contact: Sébastien GOUY, Doctor       sebastien.gouy@igr.fr   
Principal Investigator: Sébastien GOUY         
Sponsors and Collaborators
UNICANCER
Investigators
Principal Investigator: Jean-Marc CLASSE Centre rené Gauducheau, NANTES
  More Information

No publications provided

Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT01376752     History of Changes
Other Study ID Numbers: FEDEGYN 02 / 0410-CHIPOR, 2010-023035-42
Study First Received: March 28, 2011
Last Updated: December 6, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on August 28, 2014