Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) in Relapse Ovarian Cancer Treatment (CHIPOR)
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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 |
- 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.
- 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 |
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| Contact: Anne-Laure MARTIN | +33 1 44 23 55 56 | al-martin@fnclcc.fr |
| 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 | |
| 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 May 16, 2013