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

Breast Cancer Clinical Trial

— PREPARE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02704832
• Other study ID #: IB 2015-08
• Secondary ID: ID-RCB number 20
• Status: Recruiting
• Phase: Phase 3
• First received: February 19, 2016
• Last updated: November 17, 2017
• Start date: March 2016
• Est. completion date: February 2021

Study information

• Verified date: November 2017
• Source: Institut Bergonié
• Contact: Pierre-Louis SOUBEYRAN, PU-PH
• Phone: +33 5 56 33 32 67
• Email: p.soubeyran[@]bordeaux.unciancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Bladder Cancer
• Breast Cancer
• Colorectal Cancer
• Colorectal Neoplasms
• Lung Cancer
• Lymphoma
• Ovarian Cancer
• Prostate Cancer
• Urinary Bladder Neoplasms

Intervention

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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Institut Bergonié	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

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