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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
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:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
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
Name: Julien MAZIERES, MD, phD
Affiliation: University Hospital, Toulouse
Role: PRINCIPAL_INVESTIGATOR