Breast Cancer Clinical Trial
— GERABELOfficial title:
GEriatric Determinants of Curative RAdiotherapy Scheme Choice for Breast Cancer ELderly Patient Treatment Compliance and Tolerance : GERABEL Study
Verified date | February 2022 |
Source | Centre Hospitalier Universitaire de Saint Etienne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 241 |
Est. completion date | June 26, 2020 |
Est. primary completion date | June 26, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 70 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | Centre Hospitalier Emile Roux | Le Puy-en-Velay | |
France | Groupement Hospitalier Portes de Provence | Montelimar | |
France | Institut de Cancérologie Lucien Neuwirth | Saint-Priest en Jarez |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Saint Etienne | Centre Antoine Lacassagne, Institut de Cancérologie de la Loire |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Month 6 | |
Secondary | 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. | Month 6 | |
Secondary | 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. | Month 6 | |
Secondary | 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. | Month 6 | |
Secondary | 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. | Month 6 | |
Secondary | 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. | Month 6 | |
Secondary | Correlation between tolerance and the number of concomitant treatments | Correlation will potentially be established between patient general tolerance and the number of concomitant treatments. | Month 6 | |
Secondary | Correlation between tolerance and the nature of concomitant treatments | Correlation will potentially be established between patient general tolerance and the nature of concomitant treatments. | Month 6 | |
Secondary | Correlation between tolerance and the supportive cares | Correlation will potentially be established between patient general tolerance and the supportive cares performed. | Month 6 |
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