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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

September 13, 2005
July 25, 2013
September 2002
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Complete list of historical versions of study NCT00210249 on ClinicalTrials.gov Archive Site
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Development of an Evaluation Method of Elderly Condition in Patient Receiving Chemotherapy Treatment
Development of an Evaluation Method of Elderly Condition in Patient Receiving Chemotherapy Treatment . Geriatric Oncology Protocol in Aquitaine Country.

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.

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Observational
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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
  • Lymphoma
  • Digestive System Diseases
  • Ovarian Diseases
  • Pulmonary Disease
  • Prostatic Disease
  • Bladder Disease
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Hoppe S, Rainfray M, Fonck M, Hoppenreys L, Blanc JF, Ceccaldi J, Mertens C, Blanc-Bisson C, Imbert Y, Cany L, Vogt L, Dauba J, Houédé N, Bellera CA, Floquet A, Fabry MN, Ravaud A, Chakiba C, Mathoulin-Pélissier S, Soubeyran P. Functional decline in older patients with cancer receiving first-line chemotherapy. J Clin Oncol. 2013 Nov 1;31(31):3877-82. doi: 10.1200/JCO.2012.47.7430. Epub 2013 Sep 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
360
June 2006
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Inclusion criteria:

  • Age ≥ 70 years
  • First line of chemotherapy
  • Cancer previously mentioned
Both
70 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00210249
IB2002-26, ONCOGERIATRIE
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Institut Bergonié
  • Sanofi-Synthelabo
  • Aventis Pharmaceuticals
  • Amgen
  • Chugai Pharmaceutical
  • Bristol-Myers Squibb
Principal Investigator: Pierre SOUBEYRAN, MD, PhD Institut Bergonié
Institut Bergonié
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP