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

27. januar 2022 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

364

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

70 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Observationsmodeller: Kohorte
Tidsperspektiver: Fremadrettet

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Institut Bergonié

Samarbejdspartnere

Bristol-Myers Squibb

Amgen

Aventis Pharmaceuticals

Sanofi-Synthelabo

Chugai Pharmaceutical

Efterforskere

Ledende efterforsker: Pierre Soubeyran, MD, PhD, Institut Bergonie

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. september 2002

Primær færdiggørelse (Faktiske)

1. september 2007

Studieafslutning (Faktiske)

1. september 2008

Datoer for studieregistrering

Først indsendt

13. september 2005

Først indsendt, der opfyldte QC-kriterier