Development of an Evaluation Method of Elderly Condition in Patient Receiving Chemotherapy Treatment (ONCOGERIATRIE)
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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. |
Eligibility| Ages Eligible for Study: | 70 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
- 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
Inclusion criteria:
- Age ≥ 70 years
- First line of chemotherapy
- Cancer previously mentioned
Contacts and 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 | |
| Principal Investigator: | Pierre SOUBEYRAN, MD, PhD | Institut Bergonié |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00210249 History of Changes |
| Other Study ID Numbers: | IB2002-26, ONCOGERIATRIE |
| Study First Received: | September 13, 2005 |
| Last Updated: | December 29, 2011 |
| 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 June 17, 2013