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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00210249
Acronym
PHRC2003
Enrollment
364
Registered
2005-09-21
Start date
2002-09-30
Completion date
2008-09-30
Last updated
2022-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Disease, Digestive System Diseases, Lymphoma, Ovarian Diseases, Prostatic Disease, Pulmonary Disease

Keywords

Cancer, elderly, geriatric evaluation, safety, chemotherapy

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.

Interventions

None listed

Sponsors

Sanofi-Synthelabo
CollaboratorINDUSTRY
Aventis Pharmaceuticals
CollaboratorINDUSTRY
Amgen
CollaboratorINDUSTRY
Chugai Pharmaceutical
CollaboratorINDUSTRY
Bristol-Myers Squibb
CollaboratorINDUSTRY
Institut Bergonié
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participant Deaths6 months after inclusionNumber of participant deaths observed during the course of the study

Countries

France

Participant flow

Participants by arm

ArmCount
Eligible Patients
Patients satisfying eligibility criteria
364
Total364

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyLost to Follow-up5
Overall StudyProtocol Violation11

Baseline characteristics

CharacteristicEligible Patients
Age, Continuous77.45 years
Region of Enrollment
France
364 participants
Sex: Female, Male
Female
157 Participants
Sex: Female, Male
Male
207 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
56 / 348
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 0

Outcome results

Primary

Number of Participant Deaths

Number of participant deaths observed during the course of the study

Time frame: 6 months after inclusion

Population: Eleven patients did not complete the geriatric evaluation, and an additional five patients were lost to follow-up before 6 months, which left 348 analyzed patients

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Eligible PatientsNumber of Participant Deaths56 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026