NCT02824016

Evaluation of Hypothyroidism Incidence After Breast Cancer Supraclavicular Irradiation

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: Institut Jean-Godinot · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Irradiation; Adverse Effect
• Irradiation Hypothyroidism

Interventions

Type	Name	Description
BIOLOGICAL	biological sample	T4, thyrotropic-stimulating hormone (TSH) and Thyroglobulin antibody were systematically measured
RADIATION	supraclavicular irradiation	Irradiation of the homolateral supraclavicular area delivering 46 Gy in 23 fractions

Timeline

• Start date: 2013-02-01
• Primary completion: 2015-07-01
• Completion: 2020-07-01
• First posted: 2016-07-06
• Last updated: 2021-08-31

Locations

3 sites across 1 country: France