Clinical trial NCT02994914: GEriatric Determinants of Curative RAdiotherapy Scheme Choice for Breast Cancer ELderly Patient Treatment Compliance and Tolerance
Official title: GEriatric Determinants of Curative RAdiotherapy Scheme Choice for Breast Cancer ELderly Patient Treatment Compliance and Tolerance : GERABEL Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Onco Geriatric Evaluation
Radiotherapy
Hypo fractionated radiotherapy
Normo fractionated radiotherapy
Large hypo fractionated radiotherapy
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Centre Antoine Lacassagne
name: Institut de Cancérologie de la Loire
First posted: 2016-12-16
Enrollment: 241
Sex: FEMALE
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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 patients. The score obtained at this evaluation will determine the radiotherapy scheme.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Measure of the tolerance
timeFrame: Month 6
Secondary outcomes:
measure: Tolerance
timeFrame: Month 6
measure: Quality of Life Questionnaire
timeFrame: Month 6
measure: Radiotherapy compliance
timeFrame: Month 6
measure: Correlation between tolerance and distance from the therapeutic center
timeFrame: Month 6
measure: Correlation between tolerance and way of transport
timeFrame: Month 6
measure: Correlation between tolerance and the number of concomitant treatments
timeFrame: Month 6
measure: Correlation between tolerance and the nature of concomitant treatments
timeFrame: Month 6
measure: Correlation between tolerance and the supportive cares
timeFrame: Month 6
Other outcomes:
Locations:
city: Le Puy-en-Velay
country: France
facility: Centre Hospitalier Emile Roux
city: Montelimar
country: France
facility: Groupement Hospitalier Portes de Provence
city: Saint-Priest en Jarez
country: France
facility: Institut de Cancérologie Lucien Neuwirth
Study officials:
affiliation: Institut de Cancérologie Lucien Neuwirth
name: Nicolas Magné, PhD
role: PRINCIPAL_INVESTIGATOR
References: