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

NCT ID: NCT00210249

Last Updated: 2022-02-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 364 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2002-09-30
• Study Completion Date: 2008-09-30

Brief Summary

Incidence of cancer in 75+ years old is 16,500 new cases per year, more than fifty percent of people with cancerThey 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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi-Synthelabo

INDUSTRY

Sponsor Role: collaborator

Aventis Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Amgen

INDUSTRY

Sponsor Role: collaborator

Chugai Pharmaceutical

INDUSTRY

Sponsor Role: collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Institut Bergonié

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre SOUBEYRAN, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institut Bergonié

Locations

Centre de radiothérapie d'Agen

Agen, , France

Centre Hospitalier Universitaire d'Agen

Agen, , France

Clinique Esquirol Saint Hilaire

Agen, , France

Centre Hospitalier Universitaire de Bayonne

Bayonne, , France

Centre Hospitalier de la Côte Basque

Bayonne, , France

Clinique Saint Etienne du Pays Basque

Bayonne, , France

Clinique Tivoli

Bordeaux, , France

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, , France

Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest

Bordeaux, , France

Centre Hospitalier Universitaire de Dax

Dax, , France

Hopital Sub-Urbain du Bouscat

Le Bouscat, , France

Hôpital Robert Boulin

Libourne, , France

Centre Hospitalier Universitaire de Mont de Marsan

Mont-de-Marsan, , France

Centre Hospitalier Universitaire de Pau

Pau, , France

Centre Hospitalier Universitaire de Perigueux

Périgueux, , France

Clinique Francheville

Périgueux, , France

Maison de Santé Protestante Bagatelle

Talence, , France

Centre Hospitalier Universitaire de Villeneuve sur Lot

Villeneuve-sur-Lot, , France

Countries

France

References

Soubeyran P, Fonck M, Blanc-Bisson C, Blanc JF, Ceccaldi J, Mertens C, Imbert Y, Cany L, Vogt L, Dauba J, Andriamampionona F, Houede N, Floquet A, Chomy F, Brouste V, Ravaud A, Bellera C, Rainfray M. Predictors of early death risk in older patients treated with first-line chemotherapy for cancer. J Clin Oncol. 2012 May 20;30(15):1829-34. doi: 10.1200/JCO.2011.35.7442. Epub 2012 Apr 16.

Reference Type: RESULT

PMID: 22508806 (View on PubMed)

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, Houede N, Bellera CA, Floquet A, Fabry MN, Ravaud A, Chakiba C, Mathoulin-Pelissier 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.

Reference Type: DERIVED

PMID: 24062399 (View on PubMed)

Other Identifiers

PHRC OncoG

Identifier Type: OTHER

Identifier Source: secondary_id

IB2002-26

Identifier Type: -

Identifier Source: org_study_id