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Brief Title: Role of Geriatric Intervention in Treatment of Older Patients With Cancer (PREPARE)
Official Title: Role of Geriatric Intervention in Treatment of Older Patients With Cancer : a Phase III Randomized Study (PREPARE)
Study ID: NCT02704832
Brief Summary: Randomized trials have already demonstrated that geriatric intervention was able to improve survival in the general elderly population but only a few have been performed in cancer patients. At the end, these data are not sufficient to consider geriatric intervention as validated in this setting. Case Management, coordinated by a geriatrician and a trained nurse, could improve prognosis of elderly patients with cancer. This approach, can be integrated in daily oncology practice. This strategy will be compared to usual oncological management in a randomized phase III trial.
Detailed Description: Patients will first be screened using the G8 screening tool. If the resulting score is altered (G8 \<= 14), patients will be included in the main study and randomized according to 2 modalities: Arm A / Usual care (treatment according to on-going regimens in oncology) or Arm B /Case management (assessment of the patient by the nurse and the geriatrician with interventions as prescribed by the geriatrician). The intervention will be considered effective if, at one year, compared to usual care there is a significant clinical improvement in overall survival (OS) without a significant deterioration or/and clinical improvement of at least one of the targeted quality of life (QoL) scores, without significant clinical deterioration in at least one of the targeted QoL scores and without significant difference in OS in favor of usual care. If the resulting score is normal (G8 \> 14), patients will be treated according to their physician-in-charge opinion. A minimal set of data will be collected (age, sex, tumor type, disease stage, performance status (PS), creatinine clearance, albumin and C-Reactive Protein (CRP) levels mainly) to allow for the characterization of the population in order to compare our results to those of other published series.
Minimum Age: 70 Years
Eligible Ages: OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Centre Hospitalier Universitaire de Grenoble, Grenoble, Rhône Alpes, France
Institut de Cancérologie de l'Ouest, Angers, , France
Centre Hospitalier de Beauvais, Beauvais, , France
Institut Bergonié Centre Régional de Lutte Contre le Cancer, Bordeaux, , France
CHU de Bordeaux, Bordeaux, , France
Clinique Anne d'Artois, Béthune, , France
Centre Hospitalier Universitaire de Caen, Caen, , France
Infirmerie Protestante de Lyon, Caluire-et-Cuire, , France
Centre Hospitalier Intercommunal de Castres Mazamet, Castres, , France
Centre Hospitalier Métropôle Savoie Chambéry, Chambéry, , France
Centre Hospitalier de Chinon, Chinon, , France
Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, , France
Centre Jean Perrin, Clermont-Ferrand, , France
AP-HP Henri Mondor, Créteil, , France
Centre Hospitalier Intercommunal de Créteil, Créteil, , France
Centre Hospitalier de Dax, Dax, , France
Centre Georges François Leclerc, Dijon, , France
Centre Hospitalier Universitaire de Martinique, Fort De France, , France
Centre Hospitalier Emile Roux, Le Puy-en-Velay, , France
Centre Hospitalier Universitaire de Lille, Lille, , France
Clinique Mutualiste Eugène André, Lyon, , France
Hôpital Saint Joseph Saint Luc, Lyon, , France
Centre Léon Bérard, Lyon, , France
Institut Paoli Calmettes, Marseille, , France
Centre Hospitalier de Mont de Marsan, Mont de Marsan, , France
Institut de Cancérologie de Montpellier, Montpellier, , France
Institut de Cancérologie de Lorraine, Nancy, , France
Centre Catherine de Sienne, Nantes, , France
Centre Hospitalier Universitaire de Nîmes, Nîmes, , France
AP-HP Hôpital Saint Louis, Paris, , France
Centre Hospitalier de Pau, Pau, , France
Hospices Civils de Lyon, Pierre Bénite, , France
Centre CARIO - HPCA, Pleurin Sur Mer, , France
Centre Hospitalier Universitaire de Poitiers, Poitiers, , France
Centre Hospitalier René Dubos, Pontoise, , France
Centre Hospitalier Annecy Genevois, Pringy, , France
Polyclinique Francheville, Périgueux, , France
Centre Hospitalier Intercommunal de Cornouaille, Quimper, , France
Centre Jean Godinot, Reims, , France
Centre Hospitalier Universitaire de Rennes, Rennes, , France
Centre Eugène Marquis, Rennes, , France
Centre Hospitalier Universitaire de Rouen, Rouen, , France
Centre Hospitalier Privé de Saint Grégoire, Saint Grégoire, , France
Centre Hospitalier Universitaire de Nantes, Saint Herblain, , France
Centre Hospitalier de Saint-Malo, Saint-Malo, , France
GHPSO Senlis Creil Picardie, Senlis, , France
Centre Hospitalier Universitaire de Strasbourg, Strasbourg, , France
Institut Claudius Regaud, Toulouse, , France
Centre Hospitalier de Tourcoing, Tourcoing, , France
Centre Hospitalier Universitaire de Tours, Tours, , France
Name: Pierre-Louis SOUBEYRAN, PU-PH
Affiliation: Institut Bergonié
Role: STUDY_CHAIR