Evaluation of Hypothyroidism Incidence After Breast Cancer Supraclavicular Irradiation (EPITHERM)

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

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.

Study Overview

• Status: Completed
• Conditions: Irradiation; Adverse Effect; Irradiation Hypothyroidism
• Intervention / Treatment: Biological: biological sample; Radiation: supraclavicular 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

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Reims, France, 51100
    • Institut Jean Godinot
  • Strasbourg, France, 67000
    • Centre Paul Strauss
  • Vandoeuvre-les-nancy, France, 54519
    • Institut de Cancérologie de Lorraine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: with supraclavicular irradiation; 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; 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
Active Comparator: without supraclavicular irradiation; 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; T4, thyrotropic-stimulating hormone (TSH) and Thyroglobulin antibody were systematically measured

What is the study measuring?

Primary Outcome Measures

Outcome 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.

Collaborators and Investigators

• Sponsor: Institut Jean-Godinot
• Investigators: Study Director: Yacine MERROUCHE, MD, Institut Jean-Godinot

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: August 25, 2014
• First Submitted That Met QC Criteria: June 30, 2016
• First Posted (Estimate): July 6, 2016

Study Record Updates

• Last Update Posted (Actual): August 31, 2021
• Last Update Submitted That Met QC Criteria: August 30, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases; Hypothyroidism
• Other Study ID Numbers: 2013-A00755-40 (Other Identifier: RCB identifier (ANSM)); 2011-A00822-39 (Other Identifier: RCB identifier (ANSM))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED