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Spots Global Cancer Trial Database for Therapeutic Strategies in Patients With Non-squamous Non-small Cell Lung Cancer With Brain Metastases

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Trial Identification

Brief Title: Therapeutic Strategies in Patients With Non-squamous Non-small Cell Lung Cancer With Brain Metastases

Official Title: Multicentric, Randomized, Phase III Trial Comparing 2 Strategies in Patients With Non-squamous Non-small Cell Lung Cancer With Asymptomatic Brain Metastases

Study ID: NCT02162537

Study Description

Brief Summary: The patients carrying a complicated primary lung cancer brain metastases die in less than 3 months of delay disease in the absence of treatment. The median survival of these patients is approximately six months when the treatment associated with radiotherapy chemotherapy based on cisplatin is now the standard treatment. In most studies the patients die of their brain disease in one case only two, so it is likely that some patients do not require brain irradiation (prognosis in this case is linked to extra-cerebral disease ). The benefits for patients in group B (without systematic irradiation) are not to suffer the side effects of this radiation. The risks are in the same group to see brain metastases become symptomatic. The role of cerebral radiotherapy in the patients treated with chemotherapy is unclear: should all patients be irradiated systematically (since the "reference" treatment is involved and with the aim of obtaining better control of the brain lesions and maintaining a better neurological status) or should only the patients showing cerebral progression be irradiated (avoidance of possibly useless brain radiotherapy and its side effects). The aim of this study is to better determine the position of cerebral radiotherapy in this context. Main objective: determine whether there is a difference in terms of progression-free survival between a therapeutic strategy with initial systematic brain radiotherapy followed by chemotherapy cis-platine/alimta + / - Bevacizumab and strategy with an initial chemotherapy cis-platine/alimta + / - Bevacizumab associated with brain radiotherapy only in cases of cerebral progression in patients with NSCLC with asymptomatic brain metastases

Detailed Description: This is a trial comparing two strategies with the aim to determine the best place for cerebral radiotherapy (initially or only systematic progression). Arm A: Initial cerebral radiotherapy and chemotherapy, standard arm Arm B: Chemotherapy and Radiotherapy brain if clinical or radiological cerebral progression , experimental arm (The chemotherapy treatments are standard treatments using drugs with authorization in this indication)

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Centre Hospitalier, Charleville-Mézières, Ardennes, France

Centre Hospitalier du Pays d'Aix, Aix En Provence, , France

Centre Hospitalier Victor Dupouy, Argenteuil, , France

Centre d'Oncologie et de Radiothérapie du Pays Basque, Bayonne, , France

Centre Hospitalier, Beauvais, , France

Hôpital Avicenne, Bobigny, , France

HIA de Clermont-Tonnerre, Brest, , France

CHU, Brest, , France

Centre François Baclesse, Caen, , France

Centre Hospitalier Laennec, Creil, , France

Centre Hospitalier Intercommunal, Creteil, , France

Centre Hospitalier, Draguignan, , France

Centre Hospitalier, GAP, , France

Centre Hospitalier Robert Boulin, Libourne, , France

Hôpital Le Cluzeau, Limoges, , France

Centre Hospitalier Régional, Longjumeau, , France

Centre Hospitalier de Bretagne Sud, Lorient, , France

Centre Léon Bérard, Lyon, , France

Centre Hospitalier Les Chanaux, Macon, , France

Centre Hospitalier F. QUESNAY, Mantes La Jolie, , France

Institut Paoli Calmette, Marseille, , France

Hôpital Nord APHM, Marseille, , France

Centre Hospitalier, Meaux, , France

Centre Hospitalier Intercommunal, Meulan-en-Yvelines, , France

Clinique du Pont de Chaume, Montauban, , France

Centre Hospitalier, Perigueux, , France

Centre Catalan d'Oncologie, Perpignan, , France

Centre Hospitalier René Dubos, Pontoise, , France

Centre Hospitalier de la Région d'Annecy (CHRA), Pringy, , France

Centre Hospitalier Intercommunal de Cornouaille, Quimper, , France

Hôpital Pontchailloux, Rennes, , France

Hôpital Charles Nicolle, Rouen, , France

Clinique Mutualiste de l'Estuaire, Saint Nazaire, , France

Institut de Cancérologie de la Loire (I.C.L), Saint Priest En Jarez, , France

Centre Hospitalier de Salon de Provence, Salon de Provence, , France

Centre Hospitalier, Sens, , France

Centre Paul Strauss, Strasbourg, , France

Hopital d'Instruction des Armées Sainte Anne, Toulon, , France

Hôpital Larrey, Toulouse, , France

Clinique Pasteur, Toulouse, , France

Centre Hospitalier, Villefranche Sur Saone, , France

Contact Details

Name: Isabelle MONNET

Affiliation: Centre Hospitalier Intercommunal Créteil

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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