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Spots Global Cancer Trial Database for Lung Cancer in Women Treated With Anti-oestrogens anD Inhibitors of EGFR

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Trial Identification

Brief Title: Lung Cancer in Women Treated With Anti-oestrogens anD Inhibitors of EGFR

Official Title: Phase II Randomised Clinical Trial Evaluating an EGFR Tyrosine Kinase Inhibitor (EGFR-TKI) Versus an EGFR-TKI Combined With an Anti-oestrogen Treatment (Fulvestrant) in Women With Advanced Stage Non-squamous Lung Cancer

Study ID: NCT01556191

Study Description

Brief Summary: Lung Cancer is to become the first cause of death related to cancer in France as it's already the case in United States. At Present, Lung Cancer in women and in men is treated similarly. Nevertheless, numerous studies shows that lung cancer in women has specificities : at the time of the diagnosis female patients are younger, there are less clinical signs, clinical stages are earlier, histology is often adenocarcinoma. The link with tabagism is weaker . Sensitivity to tabagism is higher (more cancer in women with the same tabagism). Response rate to chemotherapy is better. Prognosis is better Numerous hypotheses have been put forward to account for the specific characteristics of female lung cancer described above. * One hypothesis is that there are different genetic anomalies in women. Some studies show an increase of EGFR mutation and HER2 expression and a decrease of expression of repair enzymes (ERCC1, RRM1, BRCA) which can explain the increase sensitivity to tabagism and to chemotherapy. * Another hypothesis is that hormones play a role in oncogenesis. Indeed, lung cancer presents hormonal risk factors : pre-menopause, less than 3 kids, short menstrual cycle, hormone replacement therapy. Estrogens would have a deleterious effect on cancer incidence and on survival of lung cancer in women. Cellular and animal models show that ER pathway is activated in lung cancer and participates in oncogenesis. * Moreover an interaction between RE and EGFR pathway has been demonstrated on lung cancer cell lines and mouse models. EGFR-TKI have shown benefit in women with wild type EGFR or unknown status (with erlotinib) and in women with EGFR mutations (with gefitinib). In this study, the use of these two treatment will be in accordance with their market authorisations. The objective of this study is to test the addition of an anti-estrogen (fulvestrant) to EGFR-TKI. Fulvestrant is a pure anti-oestrogen that binds to ER, blocks it and accelerates its breakdown. It has a market authorisation in breast cancer. Furthermore the association between EGFR-TKI and anti-estrogen could have a synergetic effect due to interaction between RE and EGFR pathways .

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Annemasse - CH, Ambilly, , France

Clinique de l'Europe, Amiens, , France

Angers - CHU, Angers, , France

CH de la C么te Basque, Bayonne, , France

CHU Besancon - Pneumologie, Besancon, , France

Bobigny - H么pital Avicenne, Bobigny, , France

H么pital Ambroise Par茅 - Pneumologie, Boulogne, , France

HCL H么pital Louis Pradel, Bron, , France

B茅ziers - CH, B茅ziers, , France

Caen - Centre Fran莽ois Baclesse, Caen, , France

Caen - CHU C么te de Nacre, Caen, , France

Cahors - CH, Cahors, , France

Chamb茅ry - CH, Chamb茅ry, , France

Centre Hospitalier, Chauny, , France

H么pital de Cholet - Pneumologie, Cholet, , France

Clamart - H么pital Percy, Clamart, , France

CHU, Clermont-Ferrand, , France

CH, Colmar, , France

Clinique des C猫dres, Cornebarrieu, , France

Cr茅teil - CHI, Cr茅teil, , France

CH de Dax, Dax, , France

Dijon - CAC, Dijon, , France

Grenoble - CHU, Grenoble, , France

Chartres - CH, Le Coudray, , France

Centre Hospitalier - Pneumologie, Le Mans, , France

CHU (H么pital Calmette) - Pneumologie, Lille, , France

CH, Longjumeau, , France

H么pital Nord - Oncologie Multidisciplinaire & Innovations Th茅rapeutiques, Marseille, , France

Institut Paoli Calmette, Marseille, , France

Polyclinique du Val de Sambre, Maubeuge, , France

Mont de Marsan - CH, Mont de Marsan, , France

Mulhouse - CH, Mulhouse, , France

CHU Nancy, Nancy, , France

Nantes - Centre Ren茅 Gauducheau, Nantes, , France

Nevers - CH, Nevers, , France

Centre Antoine Lacassagne, Nice, , France

Hopital Tenon - Pneumologie, Paris, , France

HIA Val-de-Gr芒ce, Paris, , France

H么pital Bichat - Claude - Bernard, Paris, , France

H么pital Europ茅en Georges Pompidou, Paris, , France

H么pital Saint-Joseph, Paris, , France

Paris - Curie, Paris, , France

Pau - CH, Pau, , France

Perpignan - Ch, Perpignan, , France

HCL - Lyon Sud (Pneumologie), Pierre B茅nite, , France

Centre Hospitalier, Rambouillet, , France

CHU de Reims, Reims, , France

Institut Jean Godinot, Reims, , France

Rouen - CHU, Rouen, , France

Saint Quentin - CH, Saint Quentin, , France

Strasbourg - NHC, Strasbourg, , France

Suresnes - Hopital Foch, Suresnes, , France

Centre Hospitalier Intercommunal, Toulon, , France

Clinique Pasteur, Toulouse, , France

Toulouse - CHU Larrey, Toulouse, , France

Tourcoing - CH, Tourcoing, , France

CHU Tours - Pneumologie, Tours, , France

Versailles - CH, Versailles, , France

CHI de la Haute-Sa么ne - Pneumologie, Vesoul, , France

CH de Villefranche - Pneumologie, Villefranche, , France

Institut Gustave Roussy, Villejuif, , France

Contact Details

Name: Julien MAZIERES, MD, phD

Affiliation: University Hospital, Toulouse

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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