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Breast CancerGERABELNCT02994914

GEriatric Determinants of Curative RAdiotherapy Scheme Choice for Breast Cancer ELderly Patient Treatment Compliance and Tolerance

A study testing Onco Geriatric Evaluation in people with Breast Cancer, run by Centre Hospitalier Universitaire de Saint Etienne at 3 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study proposes an onco geriatric evaluation (Activities of Daily Living, Instrumental Activities Of Daily Living, Mini Mental State Examination, mini Geriatric Depression Scale, Mini Nutritional Assessment, Cumulative Illness Rating Scale-Geriatric, and " timed get up and go " tests) for elderly breast cancer… Read more about this study

Who is it for?
Ages 70 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Onco Geriatric Evaluation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
241 participants
Where
3 sitesFrance
Study dates
5 Dec 2016to 26 Jun 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • Women only
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Woman more than 70 years old,
  • Patient carrying a breast cancer proven histologically and treated by radiotherapy in curative intent.

Who cannot join

  • Man,
  • Patient with metastatic cancer,
  • Patient with impossible follow-up at 6 months (planned relocation, patient support in another Center),
  • Patient under protection of justice or unable to give consent.

Trial locations and contacts

3 sites in 1 country.

France3 sites

  • Centre Hospitalier Emile Roux

    Le Puy-en-Velay, 43000

  • Groupement Hospitalier Portes de Provence

    Montélimar, 26216

  • Institut de Cancérologie Lucien Neuwirth

    Saint-Priest-en-Jarez, 42270

Other trials in France

About this study

Official title: GEriatric Determinants of Curative RAdiotherapy Scheme Choice for Breast Cancer ELderly Patient Treatment Compliance and Tolerance : GERABEL Study

This study proposes an onco geriatric evaluation (Activities of Daily Living, Instrumental Activities Of Daily Living, Mini Mental State Examination, mini Geriatric Depression Scale, Mini Nutritional Assessment, Cumulative Illness Rating Scale-Geriatric, and " timed get up and go " tests) for elderly breast cancer patients. The score obtained at this evaluation will determine the radiotherapy scheme.

Read the detailed description

Breast cancer is the most frequent cancer for elderly women and represents the first mortality cause for them. Breast cancer incidence increases for elderly women and will become a major public health problem in the next years.

The principal therapeutic solution is the partial mastectomy associated to radiotherapy. However, the radiotherapy scheme and its role are debated for elderly patients. Hypo fractionated radiotherapy could be considered as an advantageous option.

The treatment duration (6,5 weeks) and direct and indirect fatigue (around 33 travels) are major cons. Thereby, for elderly patients, the selection of patients who will benefit from a shorter treatment could be really difficult. It would be interesting to define an objective scoring, predicting a bad or good tolerance and observance to the radiotherapy. Nowadays, onco geriatric evaluations are used to decide some treatment's decision, but no study compared different orientated radiotherapy schemes.

The present study proposes an onco geriatric evaluation leading to a score according to seven tests (Activities of Daily Living, Instrumental Activities Of Daily Living, Mini Mental State Examination, mini Geriatric Depression Scale, Mini Nutritional Assessment, Cumulative Illness Rating Scale-Geriatric, and " timed get up and go " tests). The score will then determine an adapted radiotherapy scheme.

Conditions
Breast Cancer
Being tested
Onco Geriatric Evaluation
Keywords
Breast Cancer, Onco Geriatric Evaluation, Radiotherapy, Hypo fractionated radiotherapy, Normo fractionated radiotherapy, Large hypo fractionated radiotherapy
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Onco Geriatric EvaluationOther

    Seven tests will be performed by an onco geriatrician : Activities of Daily Living, Instrumental Activities Of Daily Living, Mini Mental State Examination, mini Geriatric Depression Scale, Mini Nutritional Assessment, Cumulative Illness Rating Scale-Geriatric, and " timed get up and go " tests. Those tests lead to a score, and this score will determine the scheme of patients radiotherapy.

Study groups in NCT02994914
Study groupRoleWhat they receive
Score of the Onco Geriatric Evaluation between 200 et 160ExperimentalAccording to the score obtained with the onco geriatric evaluation, patients with a score between 200 and 160 will receive a normo fractionated radiotherapy (66 Grays in 33 fractions). This scheme of radiotherapy is already used in the clinical practice, but not allocated according to a score obtained at an oncogeriatric evaluation.
Receives: Other: Onco Geriatric Evaluation
Score of the Onco Geriatric Evaluation between 159 et 120ExperimentalAccording to the score obtained with the onco geriatric evaluation, patients with a score between 159 and 120 will receive an hypo fractionated radiotherapy (42,56 Grays in 16 fractions). This scheme of radiotherapy is already used in the usual practice, but not allocated according to a score obtained at an oncogeriatric evaluation.
Receives: Other: Onco Geriatric Evaluation
Score of the Onco Geriatric Evaluation inferior to 119ExperimentalAccording to the score obtained with the onco geriatric evaluation, patients with a score inferior to 119 will receive a large hypo fractionated radiotherapy (30 Grays in 5 weekly fractions). This scheme of radiotherapy is already used in the usual practice, but not allocated according to a score obtained at an oncogeriatric evaluation.
Receives: Other: Onco Geriatric Evaluation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Measure of the tolerance

    Tolerance is considered as " bad " if the score of the onco geriatric evaluation decreases of more than 20% from the initial evaluation to 6 months after the end of the rays. Tolerance is considered as "correct" in the other cases.

    Measured: Month 6

Secondary outcomes (8)

  1. Tolerance

    Specific tolerance will be evaluated by the number of radiation-induced toxicities (Common Terminology Criteria for Adverse Events 4.4) of I, II, III, and IV grades.

    Measured: Month 6

  2. Quality of Life Questionnaire

    Quality of life will be assessed with the difference between the Quality of Life Questionnaire 30 of the European Organisation for Research and Treatment of Cancer (EORTC) score obtained before the radiotherapy and 6 months after the end of the radiation therapy.

    Measured: Month 6

  3. Radiotherapy compliance

    Compliance is considered as "bad" if the treatment plan is interrupted for at least one day (for medical reason). Compliance is considered as "correct" in the other cases.

    Measured: Month 6

  4. Correlation between tolerance and distance from the therapeutic center

    Correlation will potentially be established between patient general tolerance and the distance between home and radio therapeutic center.

    Measured: Month 6

  5. Correlation between tolerance and way of transport

    Correlation will potentially be established between patient general tolerance and the way of transport used by the patient to go to the therapeutic center.

    Measured: Month 6

  6. Correlation between tolerance and the number of concomitant treatments

    Correlation will potentially be established between patient general tolerance and the number of concomitant treatments.

    Measured: Month 6

  7. Correlation between tolerance and the nature of concomitant treatments

    Correlation will potentially be established between patient general tolerance and the nature of concomitant treatments.

    Measured: Month 6

  8. Correlation between tolerance and the supportive cares

    Correlation will potentially be established between patient general tolerance and the supportive cares performed.

    Measured: Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2016 (estimated)
  2. Study start5 Dec 2016
  3. Primary completion26 Jun 2020
  4. Study completion26 Jun 2020

Why it stopped: Low rythm of inclusions

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
241 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02994914
Sponsor's protocol ID
2016-0902
Other IDs
2016-A01469-42
Acronym
GERABEL
Status last verified
Feb 2022
First submitted
21 Sep 2016
Last updated
22 Feb 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Onco Geriatric Evaluation in people with Breast Cancer, run by Centre Hospitalier Universitaire de Saint Etienne at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Low rythm of inclusions). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measure of the tolerance (time frame: Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02994914.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2022.

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