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

Primary Purpose

Irradiation; Adverse Effect, Irradiation Hypothyroidism

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

biological sample

supraclavicular irradiation

About this trial

This is an interventional other trial for Irradiation; Adverse Effect

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Institut Jean Godinot
Centre Paul Strauss
Institut de Cancerologie de Lorraine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

with supraclavicular irradiation

without supraclavicular irradiation

Arm Description

Patients received supraclavicular irradiation according to local policies. Biological samples were obtained in order to evaluate hypothyroidism during the follow-up period

Patients did not receive supraclavicular irradiation according to local policies. Biological samples were obtained in order to evaluate hypothyroidism during the follow-up period

Outcomes

Primary Outcome Measures

Number of patients with treatment-related adverse effects on thyroid function as assessed by CTCAE v4.0

Secondary Outcome Measures

Full Information

NCT ID

NCT02824016

First Posted

August 25, 2014

Last Updated

August 30, 2021

Sponsor

Institut Jean-Godinot

1. Study Identification

Unique Protocol Identification Number

NCT02824016

Brief Title

Evaluation of Hypothyroidism Incidence After Breast Cancer Supraclavicular Irradiation

Acronym

EPITHERM

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

February 2013 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

July 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Institut Jean-Godinot

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Irradiation; Adverse Effect, Irradiation Hypothyroidism

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

500 (Actual)

8. Arms, Groups, and Interventions

Arm Title

with supraclavicular irradiation

Arm Type

Active Comparator

Arm Description

Patients received supraclavicular irradiation according to local policies. Biological samples were obtained in order to evaluate hypothyroidism during the follow-up period

Arm Title

without supraclavicular irradiation

Arm Type

Active Comparator

Arm Description

Patients did not receive supraclavicular irradiation according to local policies. Biological samples were obtained in order to evaluate hypothyroidism during the follow-up period

Intervention Type

Biological

Intervention Name(s)

biological sample

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

supraclavicular irradiation

Intervention Description

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

Primary Outcome Measure Information:

Title

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.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yacine MERROUCHE, MD

Organizational Affiliation

Institut Jean-Godinot

Official's Role

Study Director

Facility Information:

Facility Name

Institut Jean Godinot

City

Reims

ZIP/Postal Code

51100

Country

France

Facility Name

Centre Paul Strauss

City

Strasbourg

ZIP/Postal Code

67000

Country

France

Facility Name

Institut de Cancerologie de Lorraine

City

Vandoeuvre-les-nancy

ZIP/Postal Code

54519

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Evaluation of Hypothyroidism Incidence After Breast Cancer Supraclavicular Irradiation

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