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

NCT00210249 | Completed Results

• 2 other identifiers: IB2002-26PHRC OncoG
• Study Type: observational
• Target: 364
• Locations: 1 country
• Sites: 18

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

Keywords

Cancer; elderly; geriatric evaluation; safety; chemotherapy

Outcome Measures

Primary Outcomes (1)

• Number of Participant Deaths

  Number of participant deaths observed during the course of the study

  6 months after inclusion

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• Institut Bergonié: lead
• Sanofi-Synthelabo: collaborator
• Aventis Pharmaceuticals: collaborator
• Amgen: collaborator
• Chugai Pharmaceutical: collaborator
• Bristol-Myers Squibb: collaborator

Study Sites (18)

Centre de radiothérapie d'Agen

Agen, 47000, France

Location

Centre Hospitalier Universitaire d'Agen

Agen, 47000, France

Location

Clinique Esquirol Saint Hilaire

Agen, 47000, France

Location

Centre Hospitalier Universitaire de Bayonne

Bayonne, 64000, France

Location

Centre Hospitalier de la Côte Basque

Bayonne, 64100, France

Location

Clinique Saint Etienne du Pays Basque

Bayonne, 64100, France

Location

Clinique Tivoli

Bordeaux, 33000, France

Location

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, 33076, France

Location

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

Bordeaux, 33076, France

Location

Centre Hospitalier Universitaire de Dax

Dax, 40100, France

Location

Hopital Sub-Urbain du Bouscat

Le Bouscat, 33110, France

Location

Hôpital Robert Boulin

Libourne, 33500, France

Location

Centre Hospitalier Universitaire de Mont de Marsan

Mont-de-Marsan, 40000, France

Location

Centre Hospitalier Universitaire de Pau

Pau, 64000, France

Location

Centre Hospitalier Universitaire de Perigueux

Périgueux, 24000, France

Location

Clinique Francheville

Périgueux, 24000, France

Location

Maison de Santé Protestante Bagatelle

Talence, 33400, France

Location

Centre Hospitalier Universitaire de Villeneuve sur Lot

Villeneuve-sur-Lot, 47000, France

Location

Related Publications (2)

• 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.

  PMID: 22508806 RESULT

• 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.

  PMID: 24062399 DERIVED

MeSH Terms

Conditions

Lymphoma; Digestive System Diseases; Ovarian Diseases; Lung Diseases; Prostatic Diseases; Urinary Bladder Diseases; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Respiratory Tract Diseases; Genital Diseases, Male; Male Urogenital Diseases; Urologic Diseases

Results Point of Contact

• Title: Pr Simone Mathoulin-Pélissier
• Organization: Institut Bergonié, Comprehensive Cancer Center, Bordeaux, FR

s.mathoulin@bordeaux.unicancer.fr

+33 (0)5 56 33 33 33

Study Officials

• Pierre SOUBEYRAN, MD, PhD

  Institut Bergonié

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: September 1, 2002
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2008
• Last Updated: February 4, 2022
• Results First Posted: January 12, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (18)