Evaluation of Hypothyroidism Incidence After Breast Cancer Supraclavicular Irradiation

Study Overview
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Brief Summary
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Prospective, multicentric, comparative, non randomised, in current care. Primary objective: To evaluate the incidence of hypothyroidism in breast cancer patients treated by radiotherapy including the supra-clavicular area over a period of 5 years (60 months). Secondary objectives : To calculate the dose of irradiation received by thyroid gland during the treatment. To compare the rate of incidence of hypothyroidism in women who received a supra-clavicular irradiation (group 1)and in those who did not (group 2). To estimate and compare the rate of incidence of chronic thyroid lesions in the 2 groups. To look for predictive factors of hypothyroidism de novo in group 1 women particularly regarding the dose-volume parameters. To propose recommendations for the thyroid follow-up after supra-clavicular irradiation.

Detailed Description
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Prospective, multicentric, comparative, non randomised, in current care study 2 patient groups, non randomised, according to the necessity or not to perform a supra-clavicular irradiation: Group 1 : patients receiving a supra-clavicular irradiation Group 2 : patients not receiving a supra-clavicular irradiation. Schedule Projected inclusion duration of 18 months (duration to possibly adapt in order to obtain the number of required patients) Intermediate study of the results in 30 months Duration of follow-up of 60 months

Official Title
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A Prospective Multicentric Evaluation of the Rate of Incidence of Hypothyroidism After Supraclavicular Irradiation for Breast Cancer

Conditions
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Irradiation; Adverse Effect, Irradiation Hypothyroidism

Intervention / Treatment
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* Biological: biological sample
* Radiation: supraclavicular irradiation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women older than 18 Non metastatic breast cancer, histologically proved, whatever T and N stages and receptors status. Breast cancer treated by surgery (either initial treatment then biotherapies and/or neoadjuvant chemotherapy, either secondarily after biotherapies and/or neoadjuvant chemotherapy, either without chemotherapy and/or biotherapies) Breast cancer requiring an adjuvant radiotherapy Treatment by radiotherapy made in participating centers Information of patient and signature of the informed consent. Exclusion Criteria: Pre-existent dysthyroidism revealed before radiotherapy or at inclusion checkup (THS lower or superior to the standard of the laboratory, whatever the rate of free T4) History of thyroid surgery Bilateral breast cancer History of cervical and/or supra-clavicular radiotherapy Lack of social security insurance Subjects deprived of free behavior or under administrative control

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: with supraclavicular irradiation<br>Patients received supraclavicular irradiation according to local policies. Biological samples were obtained in order to evaluate hypothyroidism during the follow-up period | Biological: biological sample<br>* T4, thyrotropic-stimulating hormone (TSH) and Thyroglobulin antibody were systematically measured<br>Radiation: supraclavicular irradiation<br>* Irradiation of the homolateral supraclavicular area delivering 46 Gy in 23 fractions<br>|
| Active Comparator: without supraclavicular irradiation<br>Patients did not receive supraclavicular irradiation according to local policies. Biological samples were obtained in order to evaluate hypothyroidism during the follow-up period | Biological: biological sample<br>* T4, thyrotropic-stimulating hormone (TSH) and Thyroglobulin antibody were systematically measured<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with treatment-related adverse effects on thyroid function as assessed by CTCAE v4.0 |  | Outcome measures will be assessed every 6 months up to 5 years. |