Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) in Relapse Ovarian Cancer Treatment
Conditions
Ovarian Epithelial Cancer Recurrent
Conditions: official terms
Neoplasms, Glandular and Epithelial - Ovarian Neoplasms
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: maximal cytoreductive surgery
Type: Procedure
Overall Status
Recruiting
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
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.
Locations
Centre Paul Papin
Angers Cedex 9, France
Status: Recruiting
Contact: Gérard LORIMIER, Doctor - g.lorimier@angers.fnclcc.fr
Centre Hospitaleir Universitaire Jean Minjoz
Besancon, France
Status: Not yet recruiting
Contact: Elsa KALBACHER, Dr - ekalbacher@gmail.com
Institut Bergonie
Bordeaux Cedex, France
Status: Recruiting
Contact: Frédéric GUYON, Doctor - guyon@bergonie.org
Centre Francois Baclesse
Caen Cedex 3, France
Status: Not yet recruiting
Contact: Jean-Marc GUILLOIT, Doctor - jm.guilloit@baclesse.fr
Centre Jean Perrin
Clermont-ferrand Cedex 1, France
Status: Recruiting
Contact: Christian POMEL, Pr - Christophe.POMEL@cjp.fr
CHU Grenoble
Grenoble, France
Status: Not yet recruiting
Contact: Fabien PETITPERRIN - FPetitperrin@chu-grenoble.fr
Centre Oscar Lambret
Lille, France
Status: Recruiting
Contact: Eric LEBLANC, Dr - e-leblanc@o-lambret.fr
Centre Hospitalier Universitaire Dupuytren
Limoges, France
Status: Recruiting
Contact: Sylvaine DURAND-FONTANIER, Doctor - sylvainedurand-fontanier@voila.fr
Centre Leon Berard
Lyon Cedex 08, France
Status: Recruiting
Contact: Pierre MEEUS, Doctor - MEEUS@lyon.fnclcc.fr
Institut Paoli Calmettes
Marseille Cedex 9, France
Status: Recruiting
Contact: Gilles HOUVENAEGHEL, Pr - houvenaeghelg@marseille.fnclcc.fr
CRLC Val d'Aurelle
Montpellier, France
Status: Recruiting
Contact: François QUENET - francois.quenet@montpellier.unicancer.fr
Centre Hospitalier Universitaire Nice - Hopital L'Archet 2
Nice Cedex 3, France
Status: Not yet recruiting
Contact: Jean-Marc BEREDER, Dr - ber224@chu-nice.fr
Hopital Lariboisiere
Paris, France
Status: Not yet recruiting
Contact: Marc POCARD - marc.pocard@lrb.aphp.fr
Hopital Tenon
Paris, France
Status: Not yet recruiting
Contact: Valeria LOI, Dr - valeria.loi@tnn.aphp.fr
Institute Curie
Paris, France
Status: Recruiting
Contact: Bernard BARANGER - bernard.baranger@curie.net
Centre Hopsitalier Lyon Sud
Pierre-benite Cedex, France
Status: Recruiting
Contact: Olivier GLEHEN, Professor - olivier.glehen@chu-lyon.fr
Centre Jean Godinot
Reims Cedex, France
Status: Not yet recruiting
Contact: David KERE, Dr - david.kere@reims.fnclcc.fr
Centre Hospitalier Universitaire Saint Etienne- Hopital Nord
Saint-etienne, France
Status: Not yet recruiting
Contact: Karine ABBOUD, Dr - abboud_go@yahoo.fr
Ico-Centre Rene Gauducheau
Saint-herblain Cedex, France
Status: Recruiting
Contact: Jean-Marc CLASSE, Professor - jm-classe@nantes.fnclcc.fr
CHU Hautepierre
Strasbourg, France
Status: Not yet recruiting
Contact: Cécile BRIGAND - cecile.brigand@chru-strasbourg.fr
Institut Claudius Regaud
Toulouse Cedex, France
Status: Recruiting
Contact: Gwenaël FERRON, Doctor - ferron.gwenael@claudiusregaud.fr
Centre Alexis Vautrin
Vandoeuvre-les-nancy Cedex, France
Status: Recruiting
Contact: Frédéric MARCHAL, Pr - f.marchal@nancy.fnclcc.fr
Institut Gustave Roussy
Villejuif, France
Status: Recruiting
Contact: Sébastien GOUY, Doctor - sebastien.gouy@igr.fr
Start Date
April 2011
Completion Date
December 2018
Sponsors
UNICANCER
Source
UNICANCER
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page