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

January 27, 2022 updated by: 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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

364

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participant Deaths
Time Frame: 6 months after inclusion
Number of participant deaths observed during the course of the study
6 months after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Bergonié

Collaborators

Bristol-Myers Squibb
Amgen
Aventis Pharmaceuticals
Sanofi-Synthelabo
Chugai Pharmaceutical

Investigators

  • Principal Investigator: Pierre Soubeyran, MD, PhD, Institut Bergonié

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2002

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Actual)

February 4, 2022

Last Update Submitted That Met QC Criteria

January 27, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IB2002-26
  • PHRC OncoG (Other Identifier: Institut Bergonié)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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