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| Name | Class |
|---|---|
| University Hospital, Caen | OTHER |
| Groupe Francais De Pneumo-Cancerologie | OTHER |
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Our hypothesis is that the addition of bevacizumab to the standard chemotherapy treatment of MPM will improve overall survival and quality of life beyond that achieved with chemotherapy alone.
A phase II trial associating the reference chemotherapy (pemetrexed plus cisplatin) with bevacizumab is needed to ensure that no specific toxicity is induced by this association, and that this triplet have interesting activity. As pleural mesothélioma is a rare tumor, a phase III trial, using the survival data from the phase II part study, will be able to include a sufficient number of patients, in a reasonable period of time, to answer the question of efficacy of the anti-angiogenic triplet, providing the efficacy outcomes could be considered as favorable, at the end of the phase II part of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Standard Chemotherapy |
|
| 2 | Experimental | Standard Chemotherapy + bevacizumab (Avastin) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Chemotherapy (Pemetrexed and Cisplatin) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| % of patients with controled disease (responder and stable patients) at 6 months | 3-month |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | month | |
| Number of participants with treatment-related adverse events as assessed by CTCAE v3.0 | month |
| Measure | Description | Time Frame |
|---|---|---|
| Medico-economic assessments of drugs (direct/indirect costs) | 3-month |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gilles Robinet, Dr | GFPC | Study Director |
| Arnaud Scherpereel, Dr | Intergroupe Francophone de Cancerologie Thoracique | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier du Pays d'Aix | Aix-en-Provence | France | ||||
| Annemasse - CH |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26719230 | Result | Zalcman G, Mazieres J, Margery J, Greillier L, Audigier-Valette C, Moro-Sibilot D, Molinier O, Corre R, Monnet I, Gounant V, Riviere F, Janicot H, Gervais R, Locher C, Milleron B, Tran Q, Lebitasy MP, Morin F, Creveuil C, Parienti JJ, Scherpereel A; French Cooperative Thoracic Intergroup (IFCT). Bevacizumab for newly diagnosed pleural mesothelioma in the Mesothelioma Avastin Cisplatin Pemetrexed Study (MAPS): a randomised, controlled, open-label, phase 3 trial. Lancet. 2016 Apr 2;387(10026):1405-1414. doi: 10.1016/S0140-6736(15)01238-6. Epub 2015 Dec 21. | |
| 37393757 |
| Label | URL |
|---|---|
| Official website | View source |
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| Standard Chemotherapy (Pemetrexed and Cisplatin) + Bevacizumab | Drug |
|
|
| Ambilly |
| 74100 |
| France |
| Amiens - CHU | Amiens | France |
| Clinique de l'Europe | Amiens | France |
| Angers - CHU | Angers | 49000 | France |
| Auxerre - CH | Auxerre | 89011 | France |
| CHU Besancon - Pneumologie | Besançon | 25000 | France |
| Béziers - CH | Béziers | 34525 | France |
| Bobigny - Hôpital Avicenne | Bobigny | 93000 | France |
| Bois-Guillaume - CHU | Bois-Guillaume | France |
| Boujan sur Libron - Polyclinique Saint-Privat | Boujan-sur-Libron | France |
| Hôpital Ambroise Paré - Pneumologie | Boulogne | France |
| Brest - CHU | Brest | France |
| Brest - HIA | Brest | France |
| Caen - Centre François Baclesse | Caen | 14000 | France |
| CHU - Pneumologie | Caen | 14000 | France |
| Chauny - CH | Chauny | France |
| Cherbourg - CH | Cherbourg | France |
| Hôpital Percy-Armées - Pneumologie | Clamart | 92140 | France |
| CHU | Clermont-Ferrand | France |
| Colmar - CH | Colmar | 68000 | France |
| Créteil - CHI | Créteil | 94000 | France |
| Denain - CH | Denain | France |
| Centre Georges François Leclerc | Dijon | France |
| CHU Hôpital du Bocage | Dijon | France |
| Elbeuf - CH | Elbeuf | France |
| Evreux - CH | Évreux | France |
| Flers - CH | Flers | France |
| CHU Grenoble - pneumologie | Grenoble | 38000 | France |
| Chartres - CH | Le Coudray | 28630 | France |
| Centre Hospitalier - Pneumologie | Le Havre | 76600 | France |
| Le Havre - HPE | Le Havre | 76700 | France |
| Centre Hospitalier - Pneumologie | Le Mans | 72000 | France |
| Le Mans - Clinique Victor Hugo | Le Mans | France |
| CHU (Hôpital Calmette) - Pneumologie | Lille | 59000 | France |
| Limoges - Hôpital du Cluzeau | Limoges | 87042 | France |
| CH de Longjumeau | Longjumeau | France |
| Lorient - CHBS | Lorient | France |
| Centre Léon Bérard | Lyon | 69000 | France |
| HCL - Croix-Rousse | Lyon | 69000 | France |
| APHM - Hôpital Sainte Marguerite | Marseille | 13000 | France |
| Meaux - CH | Meaux | 77100 | France |
| Mont de Marsan - CH | Mont-de-Marsan | 40000 | France |
| Montpellier - CHRU | Montpellier | 34295 | France |
| Mulhouse - CH | Mulhouse | 68000 | France |
| CHU | Nancy | France |
| Nantes - Centre René Gauducheau | Nantes | 44805 | France |
| Narbonne - Polyclinique Le Languedoc | Narbonne | France |
| Nevers - CH | Nevers | 58033 | France |
| Nice - CAC | Nice | 06000 | France |
| Orléans - CH | Orléans | 45000 | France |
| Paray Le Monial - CH | Paray-le-Monial | France |
| Paray Le Monial - Clinique | Paray-le-Monial | France |
| Paris - Saint Louis | Paris | 75000 | France |
| APHP - Hopital Tenon - Pneumologie | Paris | 75020 | France |
| Paris - Curie | Paris | France |
| Pau - CH | Pau | 64046 | France |
| HCL - Lyon Sud (Pneumologie) | Pierre-Bénite | 69495 | France |
| CHU | Poitiers | France |
| Pontoise - CH | Pontoise | France |
| Reims - CHU | Reims | 51092 | France |
| Rennes - CHU | Rennes | 35033 | France |
| Roubaix - CH | Roubaix | 59100 | France |
| Rouen - CHU | Rouen | 76000 | France |
| Saint Brieuc - CHG | Saint-Brieuc | 22000 | France |
| Centre Etienne Dolet | Saint-Nazaire | France |
| Saint-Nazaire - CH | Saint-Nazaire | France |
| Institut de Cancérologie de la Loire | Saint-Priest-en-Jarez | France |
| Saint Quentin - CH | Saint-Quentin | 02100 | France |
| Saint-Malo - CH | St-Malo | 35403 | France |
| Strasbourg - NHC | Strasbourg | 63000 | France |
| Suresnes - Hopital Foch | Suresnes | 92151 | France |
| Thonon les bains - CH | Thonon-les-Bains | 74200 | France |
| Toulon - CHI | Toulon | 83000 | France |
| CHU Toulouse - Pneumologie | Toulouse | France |
| Tours - CHU | Tours | 37000 | France |
| CH Valence | Valence | France |
| Valenciennes - Clinique | Valenciennes | 59304 | France |
| CHI de la Haute-Saône - Pneumologie | Vesoul | France |
| CH de Villefranche - Pneumologie | Villefranche | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |
| Derived |
| Levallet G, Dubois F, Elie N, Creveuil C, Brosseau S, Danel C, Scherpereel A, Lantuejoul S, Mazieres J, Greillier L, Audigier-Valette C, Bergot E, Moro-Sibilot D, Molinier O, Lena H, Monnet I, Morin F, Gounant V, Zalcman G. VEGFR2 and CD34 expression associated with longer survival in patients with pleural mesothelioma in the IFCT-GFPC-0701 MAPS phase 3 trial. Lung Cancer. 2023 Aug;182:107287. doi: 10.1016/j.lungcan.2023.107287. Epub 2023 Jun 26. |
| 31279641 | Derived | Brosseau S, Danel C, Scherpereel A, Mazieres J, Lantuejoul S, Margery J, Greillier L, Audigier-Valette C, Gounant V, Antoine M, Moro-Sibilot D, Rouquette I, Molinier O, Corre R, Monnet I, Langlais A, Morin F, Bergot E, Zalcman G, Levallet G. Shorter Survival in Malignant Pleural Mesothelioma Patients With High PD-L1 Expression Associated With Sarcomatoid or Biphasic Histology Subtype: A Series of 214 Cases From the Bio-MAPS Cohort. Clin Lung Cancer. 2019 Sep;20(5):e564-e575. doi: 10.1016/j.cllc.2019.04.010. Epub 2019 May 13. |
| 30967649 | Derived | Ribi K, Luo W, Colleoni M, Karlsson P, Chirgwin J, Aebi S, Jerusalem G, Neven P, Di Lauro V, Gomez HL, Ruhstaller T, Abdi E, Biganzoli L, Muller B, Barbeaux A, Graas MP, Rabaglio M, Francis PA, Foukakis T, Pagani O, Graiff C, Vorobiof D, Maibach R, Di Leo A, Gelber RD, Goldhirsch A, Coates AS, Regan MM, Bernhard J; SOLE Investigators. Quality of life under extended continuous versus intermittent adjuvant letrozole in lymph node-positive, early breast cancer patients: the SOLE randomised phase 3 trial. Br J Cancer. 2019 May;120(10):959-967. doi: 10.1038/s41416-019-0435-4. Epub 2019 Apr 10. |
| ID | Term |
|---|---|
| D008654 | Mesothelioma |
| ID | Term |
|---|---|
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018301 | Neoplasms, Mesothelial |
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| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| D002945 | Cisplatin |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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