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NCT02704832

Role of Geriatric Intervention in Treatment of Older Patients With Cancer (PREPARE)

Sponsor: Institut Bergonié

View on ClinicalTrials.gov

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.

Official title: Role of Geriatric Intervention in Treatment of Older Patients With Cancer : a Phase III Randomized Study (PREPARE)

Key Details

Gender

All

Age Range

70 Years - Any

Study Type

INTERVENTIONAL

Enrollment

792

Start Date

2016-09-30

Completion Date

2025-11-05

Last Updated

2026-09-17

Healthy Volunteers

Conditions

Breast Cancer Colorectal Cancer Lung Cancer Prostate Cancer Bladder Cancer Ovarian Cancer Lymphoma

Interventions

OTHER

Geriatrician Intervention

Arm B : The duration of the geriatric intervention will be 12 months. The quality of life will be assessed every 3 months during the first year and at 18 months. The study's follow-up will last until 3 years after the enrollment of the last patient and data on vital status of the patient, weight, place of life and the status of the disease will be collected every 6 months.

Inclusion Criteria: 1. Patient older 70 years and older 2. Performance status 0 to 3 (WHO) 3. G8 and QLQ-C30 questionnaires 'score are available 4. No previous geriatric evaluation during cancer treatment 5. Locally advanced or metastatic disease : 1. 1st line medical treatment : * Breast cancer : locally advanced or metastatic disease, hormone-resistant and Her2 negative, * Colon and rectum : metastatic (unresectable metastasis), * Prostate cancer : metastatic and refractory to hormonal castration, * Bladder cancer : locally advanced or metastatic, * Ovarian cancer : advanced stage (IIb to IV), * Lung cancer : metastatic non-small cell, * Lymphomas (indolent and aggressive) 2. Or 2nd line medical treatment : * Breast cancer : locally advanced or metastatic disease, hormone-resistant and Her2 negative, * Colon and rectum : metastatic (unresectable metastasis), * Prostate cancer : metastatic and refractory to hormonal castration, * Ovarian cancer : advanced stage (IIb to IV), * Lymphomas (indolent and aggressive) 6. Life expectancy over 6 months 7. Signed informed consent 8. Patients with a French social security in compliance with the French law relating to biomedical research (Article L.1121-11 of French Public Health Code). Exclusion Criteria: 1. Patient who already received 2 medical treatment lines 2. Exclusive 1st or 2nd treatment lines of : * Hormonotherapy (except for prostate cancer : abiteratone acetate is allowed), * Surgery, * Radiotherapy, 3. "Best supportive care" treatment 4. Patient unable to understand quality of life questionnaire 5. Patient unable to follow and comply with the study procedures because of any geographical, social or psychological reasons. 6. Patient placed under guardianship 7. Planned concomitant participation to another medical interventional trial during the 12 months following the inclusion in the randomized study PREPARE 8. Previous enrolment in the present study

Locations (50)

Centre Hospitalier Universitaire de Grenoble

Grenoble, Auvergne-Rhône-Alpes, France

Institut de Cancérologie de l'Ouest

Angers, France

Centre Hospitalier de Beauvais

Beauvais, France

Clinique Anne d'Artois

Béthune, France

Institut Bergonié Centre Régional de Lutte Contre le Cancer

Bordeaux, France

CHU de Bordeaux

Bordeaux, 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

Polyclinique Francheville

Périgueux, 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

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

GHPSO Senlis Creil Picardie

Senlis, France

Centre Hospitalier de Saint-Malo

St-Malo, 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

Clinical Research Directory

Role of Geriatric Intervention in Treatment of Older Patients With Cancer (PREPARE)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (50)