Overview

This trial is active, not recruiting.

Conditions irradiation; adverse effect, irradiation hypothyroidism
Treatments biological sample, supraclavicular irradiation
Sponsor Institut Jean-Godinot
Start date February 2013
End date July 2015
Trial size 500 participants
Trial identifier NCT02824016, 2011-A00822-39, 2013-A00755-40

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model factorial assignment
Masking open label
Arm
(Active Comparator)
Patients received supraclavicular irradiation according to local policies. Biological samples were obtained in order to evaluate hypothyroidism during the follow-up period
biological sample
T4, thyrotropic-stimulating hormone (TSH) and Thyroglobulin antibody were systematically measured
supraclavicular irradiation
Irradiation of the homolateral supraclavicular area delivering 46 Gy in 23 fractions
(Active Comparator)
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 sample
T4, thyrotropic-stimulating hormone (TSH) and Thyroglobulin antibody were systematically measured

Primary Outcomes

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

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title A Prospective Multicentric Evaluation of the Rate of Incidence of Hypothyroidism After Supraclavicular Irradiation for Breast Cancer
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
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Institut Jean-Godinot.