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Development of an Evaluation Method of Elderly Condition in Patient Receiving Chemotherapy Treatment (PHRC2003)

27. januar 2022 oppdatert av: Institut Bergonié

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

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.

Studieoversikt

Status

Fullført

Forhold

Studietype

Observasjonsmessig

Registrering (Faktiske)

364

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Frankrike
- - Agen, Frankrike, 47000
    - Centre de radiothérapie d'Agen
  - Agen, Frankrike, 47000
    - Centre Hospitalier Universitaire d'Agen
  - Agen, Frankrike, 47000
    - Clinique Esquirol Saint Hilaire
  - Bayonne, Frankrike, 64100
    - Centre Hospitalier de la Côte Basque
  - Bayonne, Frankrike, 64000
    - Centre Hospitalier Universitaire de Bayonne
  - Bayonne, Frankrike, 64100
    - Clinique Saint Etienne du Pays Basque
  - Bordeaux, Frankrike, 33000
    - Clinique Tivoli
  - Bordeaux, Frankrike, 33076
    - Centre Hospitalier Universitaire De Bordeaux
  - Bordeaux, Frankrike, 33076
    - Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
  - Dax, Frankrike, 40100
    - Centre Hospitalier Universitaire de Dax
  - Le Bouscat, Frankrike, 33110
    - Hopital Sub-Urbain du Bouscat
  - Libourne, Frankrike, 33500
    - Hôpital Robert Boulin
  - Mont de Marsan, Frankrike, 40000
    - Centre Hospitalier Universitaire de Mont de Marsan
  - Pau, Frankrike, 64000
    - Centre Hospitalier Universitaire de Pau
  - Perigueux, Frankrike, 24000
    - Clinique Francheville
  - Perigueux, Frankrike, 24000
    - Centre Hospitalier Universitaire de Perigueux
  - Talence, Frankrike, 33400
    - Maison de Santé Protestante Bagatelle
  - Villeneuve sur Lot, Frankrike, 47000
    - Centre Hospitalier Universitaire de Villeneuve sur Lot

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

70 år og eldre (Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

Inclusion criteria:

Age ≥ 70 years
First line of chemotherapy
Cancer previously mentioned

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Observasjonsmodeller: Kohort
Tidsperspektiver: Potensielle

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Number of Participant Deaths Tidsramme: 6 months after inclusion	Number of participant deaths observed during the course of the study	6 months after inclusion

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Institut Bergonié

Samarbeidspartnere

Bristol-Myers Squibb

Amgen

Aventis Pharmaceuticals

Sanofi-Synthelabo

Chugai Pharmaceutical

Etterforskere

Hovedetterforsker: Pierre Soubeyran, MD, PhD, Institut Bergonie

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. september 2002

Primær fullføring (Faktiske)

1. september 2007

Studiet fullført (Faktiske)

1. september 2008

Datoer for studieregistrering

Først innsendt

13. september 2005

Først innsendt som oppfylte QC-kriteriene