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Completed

NCT Number: NCT02824016

Evaluation of Hypothyroidism Incidence After Breast Cancer Supraclavicular Irradiation

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institut Jean Godinot, Reims, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

biological sample

Biological

T4, thyrotropic-stimulating hormone (TSH) and Thyroglobulin antibody were systematically measured

supraclavicular irradiation

Radiation

Irradiation of the homolateral supraclavicular area delivering 46 Gy in 23 fractions

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Institut Jean-Godinot

Other

Registry information

Official study title

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

Acronym: EPITHERM

Important dates

Study start
2013
Primary completion
2015
Study completion
2020
First posted
Jul 6, 2016
Registry last updated
Aug 31, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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