Clinical trial NCT02704832: 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 type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Breast Cancer
Colorectal Cancer
Lung Cancer
Prostate Cancer
Bladder Cancer
Ovarian Cancer
Lymphoma
Keywords: Geriatric oncology
Intervention
Case management
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2016-03-10
Enrollment: 792
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival defined as the delay between randomization and death, all causes.
timeFrame: Year 1
measure: Health related quality of life (HR-QoL) assessed using 3 scales of European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire.
timeFrame: Year 1
Secondary outcomes:
measure: Overall survival defined as the delay between randomization and death, all causes.
timeFrame: Year 3
measure: Health related quality of life (hRQoL) assessed using 3 scales of EORTC QLQ-C30 questionnaire.
timeFrame: Year 3
measure: 6-month response rates defined as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 or Cheson criteria.
timeFrame: Month 6
measure: Toxicity graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.
timeFrame: up to 3 years
measure: Number of unscheduled hospitalizations.
timeFrame: up to 3 years
measure: Length of unscheduled hospitalizations.
timeFrame: up to 3 years
measure: For the experimental arm only: Assessment of autonomy using Activities of Daily Living (ADL) questionnaire.
timeFrame: Months 0, 6, 12
measure: For the experimental arm only: Assessment of autonomy using Instrumental Activities of Daily Living (IADL) questionnaire.
timeFrame: Months 0, 6, 12
measure: For the experimental arm only: Assessment of depression using Geriatric Depression Scale (GDS-15) scale.
timeFrame: Months 0, 6, 12
measure: For the experimental arm only: Assessment of cognitive functions using mini mental state exam (MMSE).
timeFrame: Months 0, 6, 12
measure: For the experimental arm only: Assessment of comorbidities using Cumulative Illness Rating Scale for Geriatrics (CIRS-G) scale.
timeFrame: Months 0, 6, 12
measure: For the experimental arm only: Assessment of nutritional status using mini nutritional assessment (MNA) scale.
timeFrame: Months 0, 6, 12
measure: For the experimental arm only: Assessment of mobility using get-up and Go test.
timeFrame: Months 0, 6, 12
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Centre Hospitalier Universitaire de Grenoble
state: Rhône Alpes
city: Angers
country: France
facility: Institut de Cancérologie de l'Ouest
city: Beauvais
country: France
facility: Centre Hospitalier de Beauvais
city: Bordeaux
country: France
facility: Institut Bergonié Centre Régional de Lutte Contre le Cancer
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Béthune
country: France
facility: Clinique Anne d'Artois
city: Caen
country: France
facility: Centre Hospitalier Universitaire de Caen
city: Caluire-et-Cuire
country: France
facility: Infirmerie Protestante de Lyon
city: Castres
country: France
facility: Centre Hospitalier Intercommunal de Castres Mazamet
city: Chambéry
country: France
facility: Centre Hospitalier Métropôle Savoie Chambéry
city: Chinon
country: France
facility: Centre Hospitalier de Chinon
city: Clermont-Ferrand
country: France
facility: Centre Hospitalier Universitaire de Clermont-Ferrand
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Créteil
country: France
facility: AP-HP Henri Mondor
city: Créteil
country: France
facility: Centre Hospitalier Intercommunal de Créteil
city: Dax
country: France
facility: Centre Hospitalier de Dax
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Fort De France
country: France
facility: Centre Hospitalier Universitaire de Martinique
city: Le Puy-en-Velay
country: France
facility: Centre Hospitalier Emile Roux
city: Lille
country: France
facility: Centre Hospitalier Universitaire de Lille
city: Lyon
country: France
facility: Clinique Mutualiste Eugène André
city: Lyon
country: France
facility: Hôpital Saint Joseph Saint Luc
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Mont de Marsan
country: France
facility: Centre Hospitalier de Mont de Marsan
city: Montpellier
country: France
facility: Institut de Cancérologie de Montpellier
city: Nancy
country: France
facility: Institut de Cancérologie de Lorraine
city: Nantes
country: France
facility: Centre Catherine de Sienne
city: Nîmes
country: France
facility: Centre Hospitalier Universitaire de Nîmes
city: Paris
country: France
facility: AP-HP Hôpital Saint Louis
city: Pau
country: France
facility: Centre Hospitalier de Pau
city: Pierre Bénite
country: France
facility: Hospices Civils de Lyon
city: Pleurin Sur Mer
country: France
facility: Centre CARIO - HPCA
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire de Poitiers
city: Pontoise
country: France
facility: Centre Hospitalier René Dubos
city: Pringy
country: France
facility: Centre Hospitalier Annecy Genevois
city: Périgueux
country: France
facility: Polyclinique Francheville
city: Quimper
country: France
facility: Centre Hospitalier Intercommunal de Cornouaille
city: Reims
country: France
facility: Centre Jean Godinot
city: Rennes
country: France
facility: Centre Hospitalier Universitaire de Rennes
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Rouen
country: France
facility: Centre Hospitalier Universitaire de Rouen
city: Saint Grégoire
country: France
facility: Centre Hospitalier Privé de Saint Grégoire
city: Saint Herblain
country: France
facility: Centre Hospitalier Universitaire de Nantes
city: Saint-Malo
country: France
facility: Centre Hospitalier de Saint-Malo
city: Senlis
country: France
facility: GHPSO Senlis Creil Picardie
city: Strasbourg
country: France
facility: Centre Hospitalier Universitaire de Strasbourg
city: Toulouse
country: France
facility: Institut Claudius Regaud
city: Tourcoing
country: France
facility: Centre Hospitalier de Tourcoing
city: Tours
country: France
facility: Centre Hospitalier Universitaire de Tours
Study officials:
affiliation: Institut Bergonié
name: Pierre-Louis SOUBEYRAN, PU-PH
role: STUDY_CHAIR
References:
citation: Soubeyran P, Terret C, Bellera C, Bonnetain F, Jean OS, Galvin A, Chakiba C, Zwolakowski MD, Mathoulin-Pelissier S, Rainfray M. Role of geriatric intervention in the treatment of older patients with cancer: rationale and design of a phase III multicenter trial. BMC Cancer. 2016 Dec 1;16(1):932. doi: 10.1186/s12885-016-2927-4.