Development of an Evaluation Method of Elderly Condition in Patient Receiving Chemotherapy Treatment (ONCOGERIATRIE)

This study has been completed.
Sponsor:
Collaborators:
Sanofi-Synthelabo
Aventis Pharmaceuticals
Amgen
Chugai Pharmaceutical
Bristol-Myers Squibb
Information provided by:
Institut Bergonié
ClinicalTrials.gov Identifier:
NCT00210249
First received: September 13, 2005
Last updated: July 25, 2013
Last verified: September 2005
  Purpose

Number of elderly people over 70 is increasing in France. In 2002, in the south-west, 273,741 of them were over 75 years, i.e. 9.2% of Aquitaine population. Incidence of cancer in this old age is 16,500 new cases per year, more than fifty percent of people with cancer. Treatment modalities of elderly people is one of the 70 priorities of the "Plan cancer" instituted by the French government. They are very few therapeutic trials dedicated. Oncologists hesitate to treat them because they are either afraid of inducing toxicity or of breaking down quality of life. Consequently, we decided to launch a protocol with both oncologists and geriatricians which principal aim is to find out if geriatric assessment data can help to better predict for chemotherapy toxicity, loss of autonomy and survival. We plan to accrue 360 patients diagnosed for cancer, including digestive, pulmonary, prostate, lymphoma, bladder, ovary cancer for whom first-line chemotherapy is planned. Patients are initially classified according to usual methods of medical oncology practice into three groups: patients who can receive standard treatment, reduced standard treatment or treatment adapted to the frail condition. Around Aquitaine, , we organised seven teams composed of one geriatrician and one nurse. Two kind of teams were activated: one which cover ten treatment sites in Bordeaux area and six sedentary teams which worked half a day a week in designated hospitals . Geriatric evaluation included test of cognitive functions (MMS), nutritional status (MNA), co-morbidity (CIRS-G), mobility (Get up and Go), activities (ADL;IADL), quality of life (QLQ-C30), depression (GDS-15) and Lachs-Balducci screening. Patients have four geriatric evaluations : before treatment, day 1 cycle 2, day 1 cycle 4, day 1 cycle 7 and/or end of chemotherapy. Since September 2002, 177 patients have been included, 112 have finished: 47.3% have received four evaluations, 16.1% died before the end of protocol, 14.3% stopped because they were in progression and changed their treatment, 11.6% met administrative problem that didn't allow all evaluations, 7.1% declined after inclusion and 3.6% finished their treatment before. The following results have been obtained: before treatment, 73% of these patients were at risk of undernutrition (MNA< 23.5), about 1/3 had one or more inability or a risk of falls (38% IADL<6, 29% get up and go>20seconds, 27% ADL>1, 34% PS<1), 28% of them had altered cognitive functions (MMS<24), 29% were depressive (GDS-15>6), 25% thought they had poor quality of life (QLQ-C30<4). Protocol will be closed in September 2005.


Condition
Lymphoma
Digestive System Diseases
Ovarian Diseases
Pulmonary Disease
Prostatic Disease
Bladder Disease

Study Type: Observational
Official Title: Development of an Evaluation Method of Elderly Condition in Patient Receiving Chemotherapy Treatment . Geriatric Oncology Protocol in Aquitaine Country.

Resource links provided by NLM:


Further study details as provided by Institut Bergonié:

Enrollment: 360
Study Start Date: September 2002
Study Completion Date: June 2006
  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
  • cancer du colon en indication de chimiothérapie (adjuvante ou palliative) ;
  • cancer de l'estomac en indication de chimiothérapie (d'induction ou palliative) ;
  • Cancer du pancréas en indication de chimiothérapie
  • cancer de l'ovaire en indication de chimiothérapie (adjuvante ou palliative) ;
  • tous lymphomes diffus à grandes cellules B, tous lymphomes T périphériques (la majorité de ces patients seront a priori inclus dans les essais 20991 et 20992 de l'EORTC) ;
  • tous lymphomes de faible malignité : lymphocytiques, lympho-plasmocytaires, folliculaires, manteau, zone marginale (MALT et autres).
  • Cancer de la prostate en indication de chimiothérapie
  • Cancer de la vessie en indication de chimiothérapie
  • Cancer bronchique en indication de chimiothérapie
  • Adénocarcinome de primitif inconnu compatible avec une origine citée ci-dessus en indication de chimiothérapie
Criteria

Inclusion criteria:

  • Age ≥ 70 years
  • First line of chemotherapy
  • Cancer previously mentioned
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00210249

Locations
France
Centre de radiothérapie d'Agen
Agen, France, 47000
Centre Hospitalier Universitaire d'Agen
Agen, France, 47000
Clinique Esquirol Saint Hilaire
Agen, France, 47000
Centre Hospitalier de la Côte Basque
Bayonne, France, 64100
Clinique Saint Etienne du Pays Basque
Bayonne, France, 64100
Centre Hospitalier Universitaire de Bayonne
Bayonne, France, 64000
Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
Bordeaux, France, 33076
Clinique Tivoli
Bordeaux, France, 33000
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, France, 33076
Centre Hospitalier Universitaire de Dax
Dax, France, 40100
Hopital Sub-Urbain du Bouscat
Le Bouscat, France, 33110
Hôpital Robert Boulin
Libourne, France, 33500
Centre Hospitalier Universitaire de Mont de Marsan
Mont de Marsan, France, 40000
Centre Hospitalier Universitaire de Pau
Pau, France, 64000
Clinique Francheville
Perigueux, France, 24000
Centre Hospitalier Universitaire de Perigueux
Perigueux, France, 24000
Maison de Santé Protestante Bagatelle
Talence, France, 33400
Centre Hospitalier Universitaire de Villeneuve sur Lot
Villeneuve sur Lot, France, 47000
Sponsors and Collaborators
Institut Bergonié
Sanofi-Synthelabo
Aventis Pharmaceuticals
Amgen
Chugai Pharmaceutical
Bristol-Myers Squibb
Investigators
Principal Investigator: Pierre SOUBEYRAN, MD, PhD Institut Bergonié
  More Information

No publications provided by Institut Bergonié

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00210249     History of Changes
Other Study ID Numbers: IB2002-26, ONCOGERIATRIE
Study First Received: September 13, 2005
Last Updated: July 25, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut Bergonié:
Cancer
elderly
geriatric evaluation
safety
chemotherapy

Additional relevant MeSH terms:
Urinary Bladder Diseases
Digestive System Diseases
Gastrointestinal Diseases
Lung Diseases
Respiration Disorders
Lymphoma
Ovarian Diseases
Prostatic Diseases
Urologic Diseases
Respiratory Tract Diseases
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Genital Diseases, Male

ClinicalTrials.gov processed this record on July 24, 2014