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

Lymphoma Clinical Trial

— PHRC2003  

Official title:

Development of an Evaluation Method of Elderly Condition in Patient Receiving Chemotherapy Treatment . Geriatric Oncology Protocol in Aquitaine Country.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00210249
• Other study ID #: IB2002-26
• Secondary ID: PHRC OncoG
• Status: Completed
• Start date: September 2002
• Est. completion date: September 2008

Study information

• Verified date: January 2022
• Source: Institut Bergonié
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 364
• Est. completion date: September 2008
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion criteria:

• Age = 70 years

• First line of chemotherapy

• Cancer previously mentioned

Related Conditions & MeSH terms

• Bladder Disease
• Digestive System Diseases
• Gastrointestinal Diseases
• Lymphoma
• Ovarian Diseases
• Prostatic Disease
• Prostatic Diseases
• Pulmonary Disease
• Urinary Bladder Diseases

Locations

Country	Name	City	State
France	Centre de radiothérapie d'Agen	Agen
France	Centre Hospitalier Universitaire d'Agen	Agen
France	Clinique Esquirol Saint Hilaire	Agen
France	Centre Hospitalier de la Côte Basque	Bayonne
France	Centre Hospitalier Universitaire de Bayonne	Bayonne
France	Clinique Saint Etienne du Pays Basque	Bayonne
France	Centre Hospitalier Universitaire de Bordeaux	Bordeaux
France	Clinique Tivoli	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	Perigueux
France	Clinique Francheville	Perigueux
France	Maison de Santé Protestante Bagatelle	Talence
France	Centre Hospitalier Universitaire de Villeneuve sur Lot	Villeneuve sur Lot

Sponsors (6)

Lead Sponsor	Collaborator
Institut Bergonié	Amgen, Aventis Pharmaceuticals, Bristol-Myers Squibb, Chugai Pharmaceutical, Sanofi-Synthelabo

Country where clinical trial is conducted

France, 

References & Publications (1)

Soubeyran P, Fonck M, Blanc-Bisson C, Blanc JF, Ceccaldi J, Mertens C, Imbert Y, Cany L, Vogt L, Dauba J, Andriamampionona F, Houédé N, Floquet A, Chomy F, Brouste V, Ravaud A, Bellera C, Rainfray M. Predictors of early death risk in older patients treate — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participant Deaths	Number of participant deaths observed during the course of the study	6 months after inclusion