Clinical trial NCT00210249: Development of an Evaluation Method of Elderly Condition in Patient Receiving Chemotherapy Treatment
Official title: Development of an Evaluation Method of Elderly Condition in Patient Receiving Chemotherapy Treatment . Geriatric Oncology Protocol in Aquitaine Country.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma
Digestive System Diseases
Ovarian Diseases
Pulmonary Disease
Prostatic Disease
Bladder Disease
Keywords: Cancer
elderly
geriatric evaluation
safety
chemotherapy
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
Collaborators: name: Sanofi-Synthelabo
name: Aventis Pharmaceuticals
name: Amgen
name: Chugai Pharmaceutical
name: Bristol-Myers Squibb
First posted: 2005-09-21
Enrollment: 364
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients greater than 70 year of age (no upper age limit) who were scheduled to receive first-line chemotherapy for various types of cancer (ie, colon, pancreas, stomach, ovary, bladder, prostate, lung cancer, non-Hodgkin's lymphoma \[NHL\], or cancer of unknown primary origin), excluding breast cancer, were eligible for inclusion. Patients with known CNS metastases were excluded.

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.


Eligibility criteria: Inclusion criteria:

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

Primary outcomes:
measure: Number of Participant Deaths
timeFrame: 6 months after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Agen
country: France
facility: Centre de radiothérapie d'Agen
city: Agen
country: France
facility: Centre Hospitalier Universitaire d'Agen
city: Agen
country: France
facility: Clinique Esquirol Saint Hilaire
city: Bayonne
country: France
facility: Centre Hospitalier Universitaire de Bayonne
city: Bayonne
country: France
facility: Centre Hospitalier de la Côte Basque
city: Bayonne
country: France
facility: Clinique Saint Etienne du Pays Basque
city: Bordeaux
country: France
facility: Clinique Tivoli
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire de Bordeaux
city: Bordeaux
country: France
facility: Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
city: Dax
country: France
facility: Centre Hospitalier Universitaire de Dax
city: Le Bouscat
country: France
facility: Hopital Sub-Urbain du Bouscat
city: Libourne
country: France
facility: Hôpital Robert Boulin
city: Mont de Marsan
country: France
facility: Centre Hospitalier Universitaire de Mont de Marsan
city: Pau
country: France
facility: Centre Hospitalier Universitaire de Pau
city: Perigueux
country: France
facility: Centre Hospitalier Universitaire de Perigueux
city: Perigueux
country: France
facility: Clinique Francheville
city: Talence
country: France
facility: Maison de Santé Protestante Bagatelle
city: Villeneuve sur Lot
country: France
facility: Centre Hospitalier Universitaire de Villeneuve sur Lot
Study officials:
affiliation: Institut Bergonié
name: Pierre SOUBEYRAN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.