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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00210249
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : July 26, 2013
Aventis Pharmaceuticals
Chugai Pharmaceutical
Bristol-Myers Squibb
Information provided by:
Institut Bergonié

Brief Summary:
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 or disease
Lymphoma Digestive System Diseases Ovarian Diseases Pulmonary Disease Prostatic Disease Bladder Disease

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Study Type : Observational
Actual Enrollment : 360 participants
Official Title: Development of an Evaluation Method of Elderly Condition in Patient Receiving Chemotherapy Treatment . Geriatric Oncology Protocol in Aquitaine Country.
Study Start Date : September 2002
Actual Study Completion Date : June 2006

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Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
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

Inclusion criteria:

  • Age ≥ 70 years
  • First line of chemotherapy
  • Cancer previously mentioned

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00210249

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Sponsors and Collaborators
Institut Bergonié
Aventis Pharmaceuticals
Chugai Pharmaceutical
Bristol-Myers Squibb
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Principal Investigator: Pierre SOUBEYRAN, MD, PhD Institut Bergonié

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00210249    
Other Study ID Numbers: IB2002-26
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: July 26, 2013
Last Verified: September 2005
Keywords provided by Institut Bergonié:
geriatric evaluation
Additional relevant MeSH terms:
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Gastrointestinal Diseases
Urinary Bladder Diseases
Prostatic Diseases
Ovarian Diseases
Digestive System Diseases
Urologic Diseases
Genital Diseases, Male
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases