Breast Cancer Clinical Trial
— PREPAREOfficial title:
Role of Geriatric Intervention in Treatment of Older Patients With Cancer : a Phase III Randomized Study (PREPARE)
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.
Status | Recruiting |
Enrollment | 1500 |
Est. completion date | February 2021 |
Est. primary completion date | February 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 70 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Institut de Cancérologie de l'Ouest | Angers | |
France | Centre Hospitalier de Beauvais | Beauvais | |
France | Clinique Anne d'Artois | Béthune | |
France | CHU de Bordeaux | Bordeaux | |
France | Institut Bergonié Centre Régional de Lutte Contre le Cancer | 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 Universitaire de Grenoble | Grenoble | Rhône Alpes |
France | Centre Hospitalier Emile Roux | Le Puy-en-Velay | |
France | Centre Hospitalier Universitaire de Lille | Lille | |
France | Centre Léon Bérard | Lyon | |
France | Clinique Mutualiste Eugène André | Lyon | |
France | Hôpital Saint Joseph Saint Luc | 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 Eugène Marquis | Rennes | |
France | Centre Hospitalier Universitaire de Rennes | 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 |
Lead Sponsor | Collaborator |
---|---|
Institut Bergonié | Ministry of Health, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival defined as the delay between randomization and death, all causes. | Year 1 | ||
Primary | Health related quality of life (HR-QoL) assessed using 3 scales of European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire. | Year 1 | ||
Secondary | Overall survival defined as the delay between randomization and death, all causes. | Year 3 | ||
Secondary | Health related quality of life (hRQoL) assessed using 3 scales of EORTC QLQ-C30 questionnaire. | Year 3 | ||
Secondary | 6-month response rates defined as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 or Cheson criteria. | Month 6 | ||
Secondary | Toxicity graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4. | up to 3 years | ||
Secondary | Number of unscheduled hospitalizations. | up to 3 years | ||
Secondary | Length of unscheduled hospitalizations. | up to 3 years | ||
Secondary | For the experimental arm only: Assessment of autonomy using Activities of Daily Living (ADL) questionnaire. | Months 0, 6, 12 | ||
Secondary | For the experimental arm only: Assessment of autonomy using Instrumental Activities of Daily Living (IADL) questionnaire. | Months 0, 6, 12 | ||
Secondary | For the experimental arm only: Assessment of depression using Geriatric Depression Scale (GDS-15) scale. | Months 0, 6, 12 | ||
Secondary | For the experimental arm only: Assessment of cognitive functions using mini mental state exam (MMSE). | Months 0, 6, 12 | ||
Secondary | For the experimental arm only: Assessment of comorbidities using Cumulative Illness Rating Scale for Geriatrics (CIRS-G) scale. | Months 0, 6, 12 | ||
Secondary | For the experimental arm only: Assessment of nutritional status using mini nutritional assessment (MNA) scale. | Months 0, 6, 12 | ||
Secondary | For the experimental arm only: Assessment of mobility using get-up and Go test. | Months 0, 6, 12 |
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