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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

241 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-05

Study Completion Date

2020-06-26

Brief Summary

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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.

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Detailed Description

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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

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Score of the Onco Geriatric Evaluation between 200 et 160

According 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.

Group Type EXPERIMENTAL

Onco Geriatric Evaluation

Intervention Type OTHER

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.

Score of the Onco Geriatric Evaluation between 159 et 120

According 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.

Group Type EXPERIMENTAL

Onco Geriatric Evaluation

Intervention Type OTHER

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.

Score of the Onco Geriatric Evaluation inferior to 119

According 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.

Group Type EXPERIMENTAL

Onco Geriatric Evaluation

Intervention Type OTHER

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.

Interventions

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Onco Geriatric Evaluation

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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No