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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023035-42 | EudraCT Number |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| maximal cytoreductive surgery without HIPEC | Active Comparator | The participant will have a regular cytoreductive surgery without the adjunction of HIPEC. |
|
| maximal cytoreductive surgery with HIPEC | Experimental | The participant will have a regular cytoreductive surgery, then the adjunction of HIPEC: hyperthermic cisplatin will be used at 75mg/m² |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maximal cytoreductive surgery | Procedure | Maximal cytoreductive surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | Follow-up of 4 years. | from randomization to death (up to 4 years) |
| Measure | Description | Time Frame |
|---|---|---|
| relapse free survival | Follow-up of 4 years. | from randomization to relapse (up to 4 years) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Marc CLASSE | Centre rené Gauducheau, NANTES | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Jules Bordet | Brussels | Belgium | ||||
| CHU d'AMIENS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16485159 | Result | Brigand C, Monneuse O, Mohamed F, Sayag-Beaujard AC, Isaac S, Gilly FN, Glehen O. Peritoneal mesothelioma treated by cytoreductive surgery and intraperitoneal hyperthermic chemotherapy: results of a prospective study. Ann Surg Oncol. 2006 Mar;13(3):405-12. doi: 10.1245/ASO.2006.05.041. Epub 2006 Jan 30. | |
| 16394300 | Result |
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| HIPEC | Drug | HIPEC: Hyperthermic Intra-PEritoneal Chemotherapy. Administration of cisplatin at 75mg/m² |
|
| Amiens |
| France |
| Centre Paul Papin | Angers | 49933 | France |
| Institut Bergonie | Bordeaux | 33076 | France |
| Clinique Pasteur | Brest | France |
| Polyclinique Kéraudren | Brest | France |
| Centre Francois Baclesse | Caen | 14076 | France |
| Centre Jean Perrin | Clermont-Ferrand | 63011 | France |
| Centre hospitalier de Dijon | Dijon | France |
| CHU de Grenoble | Grenoble | France |
| Clinique Victor Hugo | Le Mans | France |
| Pôle Santé Sud | Le Mans | France |
| Centre Oscar Lambret | Lille | 59020 | France |
| CHU de Lille | Lille | France |
| Centre Hospitalier Universitaire Dupuytren | Limoges | 87042 | France |
| Centre Leon Berard | Lyon | 69373 | France |
| Centre Hopsitalier Lyon Sud | Lyon | 69495 | France |
| Institut Paoli Calmettes | Marseille | 13273 | France |
| AP-HM - Hôpital de la Timone | Marseille | France |
| CRLC Val d'Aurelle | Montpellier | 34298 | France |
| Centre Hospitalier Universitaire Nice | Nice | 06202 | France |
| Hopital Lariboisiere | Paris | 75010 | France |
| Hopital Tenon | Paris | 75020 | France |
| Hôpital Européen Georges Pompidou | Paris | France |
| Institut Curie | Paris | France |
| CHU - Hôpital de la Milétrie | Poitiers | France |
| Centre Hospitalier Universitaire Saint Etienne- Hopital Nord | Saint-Etienne | 42055 | France |
| Ico-Centre Rene Gauducheau | Saint-Herblain | 44805 | France |
| CHU Hautepierre | Strasbourg | 67098 | France |
| Institut Claudius Regaud | Toulouse | 31052 | France |
| Centre Alexis Vautrin | Vandœuvre-lès-Nancy | 54511 | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |
| Hospital Universitari Germans Trias I Pujol | Badalona | Spain |
| Armstrong DK, Bundy B, Wenzel L, Huang HQ, Baergen R, Lele S, Copeland LJ, Walker JL, Burger RA; Gynecologic Oncology Group. Intraperitoneal cisplatin and paclitaxel in ovarian cancer. N Engl J Med. 2006 Jan 5;354(1):34-43. doi: 10.1056/NEJMoa052985. |
| 39549720 | Derived | Classe JM, Meeus P, Hudry D, Wernert R, Quenet F, Marchal F, Houvenaeghel G, Bats AS, Lecuru F, Ferron G, Brigand C, Berton D, Gladieff L, Joly F, Ray-Coquard I, Durand-Fontanier S, Liberale G, Pocard M, Georgeac C, Gouy S, Guilloit JM, Guyon F, Costan C, Rousselet JM, de Guerke L, Bakrin N, Brument E, Martin E, Asselain B, Campion L, Glehen O; UNICANCER/CHIPOR Investigators. Hyperthermic intraperitoneal chemotherapy for recurrent ovarian cancer (CHIPOR): a randomised, open-label, phase 3 trial. Lancet Oncol. 2024 Dec;25(12):1551-1562. doi: 10.1016/S1470-2045(24)00531-X. Epub 2024 Nov 14. |
| ID | Term |
|---|---|
| D000084262 | Hyperthermic Intraperitoneal Chemotherapy |
| ID | Term |
|---|---|
| D017024 | Chemotherapy, Adjuvant |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D006979 | Hyperthermia, Induced |
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