EPITHERM: Evaluation of Hypothyroidism Incidence After Breast Cancer Supraclavicular Irradiation

• Sponsor: Institut Jean-Godinot (Other)
• Overall Status: Completed
• CT.gov ID: NCT02824016
• Collaborator: (none)
• Enrollment: 500
• Locations: 3
• Arms: 2
• Duration (Months): 88.9
• Patients Per Site: 166.7
• Patients Per Site Per Month: 1.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Irradiation; Adverse Effect; Irradiation Hypothyroidism	Biological: biological sample; Radiation: supraclavicular irradiation	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 500 participants
• Allocation: Non-Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Prospective Multicentric Evaluation of the Rate of Incidence of Hypothyroidism After Supraclavicular Irradiation for Breast Cancer
• Study Start Date: Feb 1, 2013
• Actual Primary Completion Date: Jul 1, 2015
• Actual Study Completion Date: Jul 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut Jean Godinot	Reims		France	51100
2	Centre Paul Strauss	Strasbourg		France	67000
3	Institut de Cancerologie de Lorraine	Vandoeuvre-les-nancy		France	54519

Sponsors and Collaborators

• Institut Jean-Godinot

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tan Dat NGUYEN, Professor, Institut Jean-Godinot
• ClinicalTrials.gov Identifier: NCT02824016
• Other Study ID Numbers: 2013-A00755-40; 2011-A00822-39; 2013-A00755-40
• First Posted: Jul 6, 2016
• Last Update Posted: Aug 31, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Hypothyroidism

Study Results

No Results Posted as of Aug 31, 2021