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

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

INTRODUCTION

  • Org Study ID: IB 2015-08
  • Secondary ID: ID-RCB number 2015-A01417-42
  • NTC ID: NCT02704832
  • Sponsor: Institut Bergonié

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.


  • Overall Status
    Recruiting
  • Start Date
  • Phase
    Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Overall survival defined as the delay between randomization and death, all causes.

Primary Outcome 1 - Timeframe: Year 1

Primary Outcome 2 - 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.

Primary Outcome 2 - Timeframe: Year 1

CONDITION

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

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

Gender: All

Minimum Age: N/A

Maximum Age: 70 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Pierre-Louis SOUBEYRAN, PU-PH

Role: Study Chair

Affiliation: Institut Bergonié

Overall Contact

Name: Pierre-Louis SOUBEYRAN, PU-PH

Phone: +33 5 56 33 32 67

Email: p.soubeyran@bordeaux.unciancer.fr

LOCATION

Facility Status Contact
Facility: Centre Hospitalier Universitaire de Grenoble
Grenoble, Rhône Alpes 38043
France
Status: Recruiting Contact:
Hervé CURE, PU-PH

Facility: Institut de Cancérologie de l'Ouest
Angers,
France
Status: Recruiting Contact:
Sophie ABADIE-LACOURTOISIE, MD

Facility: Institut Bergonié Centre Régional de Lutte Contre le Cancer
Bordeaux, 33076
France
Status: Recruiting Contact:
Pierre-Louis SOUBEYRAN, PU-PH

Facility: CHU de Bordeaux
Bordeaux, 33600
France
Status: Recruiting Contact:
Jean-Frédéric BLANC, PU-PH

Facility: Centre Hospitalier Universitaire de Caen
Caen, 14033
France
Status: Recruiting Contact:
Jeannick MADELAINE, MD

Facility: Infirmerie Protestante de Lyon
Caluire-et-Cuire, 69300
France
Status: Recruiting Contact:
Sophie HUMBLOT, MD

Facility: Centre Hospitalier Intercommunal de Castres Mazamet
Castres, 81108
France
Status: Recruiting Contact:
Hazem Georges HASWANI, MD

Facility: Centre Hospitalier Métropôle Savoie Chambéry
Chambéry, 73011
France
Status: Recruiting Contact:
Isabelle CAUVIN, MD

Facility: Centre Hospitalier de Chinon
Chinon, 37500
France
Status: Recruiting Contact:
Sylvie GERARD, MD

Facility: Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand, 63000
France
Status: Recruiting Contact:
Jacques Olivier BAY, PU-PH

Facility: Centre Jean Perrin
Clermont-Ferrand, 63011
France
Status: Recruiting Contact:
Xavier DURANDO, MD

Facility: AP-HP Henri Mondor
Créteil, 94000
France
Status: Recruiting Contact:
Christophe TOURNIGAND, PU-PH

Facility: Centre Hospitalier Intercommunal de Créteil
Créteil, 94010
France
Status: Recruiting Contact:
Christos CHOUAID, MD

Facility: Centre Hospitalier de Dax
Dax, 40107
France
Status: Recruiting Contact:
Laure GAUTIER-FELIZOT, MD

Facility: Centre Georges François Leclerc
Dijon, 21079
France
Status: Recruiting Contact:
Leila BENGRINE-LEFEVRE, MD

Facility: Centre Hospitalier Universitaire de Martinique
Fort De France, 97261
France
Status: Recruiting Contact:
Nathalie GROSSAT, MD

Facility: Hôpital Saint Joseph Saint Luc
Lyon, 69007
France
Status: Recruiting Contact:
Denis PERE-VERGE, MD

Facility: Centre Léon Bérard
Lyon, 69373
France
Status: Recruiting Contact:
Catherine TERRET, MD

Facility: Institut Paoli Calmettes
Marseille, 13273
France
Status: Recruiting Contact:
Frédérique ROUSSEAU, MD

Facility: Centre Hospitalier de Mont de Marsan
Mont de Marsan, 40000
France
Status: Recruiting Contact:
Jérôme DAUBA, MD

Facility: Institut de Cancérologie de Lorraine
Nancy, 54519
France
Status: Recruiting Contact:
Cécile DELATTRE, MD

Facility: Centre Catherine de Sienne
Nantes, 44202
France
Status: Recruiting Contact:
Claude EL KOURI, MD

Facility: Centre Hospitalier Universitaire de Nîmes
Nîmes, 30029
France
Status: Recruiting Contact:
Nadine HOUEDE, PU-PH

Facility: AP-HP Hôpital Saint Louis
Paris, 75010
France
Status: Recruiting Contact:
Thomas APARICIO, MD

Facility: Centre Hospitalier de Pau
Pau, 64046
France
Status: Recruiting Contact:
Corinne DAGADA, MD

Facility: Centre CARIO - HPCA
Pleurin Sur Mer, 22190
France
Status: Recruiting Contact:
Anne-Claire HARDY-BESSARD, MD

Facility: Centre Hospitalier Universitaire de Poitiers
Poitiers, 86000
France
Status: Recruiting Contact:
Patrick BOUCHAERT, MD

Facility: Centre Hospitalier Annecy Genevois
Pringy, 74374
France
Status: Recruiting Contact:
Laetitia STEFANI, MD

Facility: Polyclinique Francheville
Périgueux, 24000
France
Status: Recruiting Contact:
Laurent CANY, MD

Facility: Centre Hospitalier Intercommunal de Cornouaille
Quimper, 29107
France
Status: Recruiting Contact:
Delphine MOLLON, MD

Facility: Centre Jean Godinot
Reims, 51726
France
Status: Recruiting Contact:
Jean-Christophe EYMARD, MD

Facility: Centre Hospitalier Universitaire de Rennes
Rennes, 35033
France
Status: Recruiting Contact:
Thierry LAMY de la CHAPELLE, MD

Facility: Centre Eugène Marquis
Rennes, 35042
France
Status: Recruiting Contact:
Christophe PERRIN, MD

Facility: Centre Hospitalier Universitaire de Rouen
Rouen, 76031
France
Status: Recruiting Contact:
Pierre MICHEL, PU-PH

Facility: Centre Hospitalier Privé de Saint Grégoire
Saint Grégoire, 35760
France
Status: Recruiting Contact:
Anne MERCIER-BLAS

Facility: Centre Hospitalier Universitaire de Nantes
Saint Herblain, 44800
France
Status: Recruiting Contact:
Stéphanie BORDENAVE, MD

Facility: Centre Hospitalier de Saint-Malo
Saint-Malo, 35403
France
Status: Recruiting Contact:
Hervé DESCLOS, MD

Facility: GHPSO Senlis Creil Picardie
Senlis, 60300
France
Status: Recruiting Contact:
Elisabeth CAROLA, MD

Facility: Centre Hospitalier Universitaire de Strasbourg
Strasbourg, 67091
France
Status: Recruiting Contact:
Jean-Emmanuel KURTZ, PU-PH

Facility: Institut Claudius Regaud
Toulouse, 31059
France
Status: Recruiting Contact:
Loïc MOUREY, MD

Facility: Centre Hospitalier Universitaire de Tours
Tours, 37170
France
Status: Recruiting Contact:
Thierry LECOMTE, MD