Irradiation; Adverse Effect, Irradiation Hypothyroidism
Conditions
Brief summary
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
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
Interventions
BIOLOGICALbiological sample
T4, thyrotropic-stimulating hormone (TSH) and Thyroglobulin antibody were systematically measured
RADIATIONsupraclavicular irradiation
Irradiation of the homolateral supraclavicular area delivering 46 Gy in 23 fractions
Sponsors
Institut Jean-Godinot
Study design
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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. |
Countries
France
Outcome results
None listed