CompletedNCT02824016EPITHERMUpdated Aug 31, 2021

Evaluation of Hypothyroidism Incidence After Breast Cancer Supraclavicular Irradiation

An interventional study of biological sample and supraclavicular irradiation in Irradiation; Adverse Effect and Irradiation Hypothyroidism, sponsored by Institut Jean-Godinot. Completed at 3 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-31.

Sponsored by Institut Jean-Godinot · Not applicable, Interventional, and Other

Phase: Not applicable
Study type: Interventional
Enrollment: 500
Allocation: Non-randomized
Ages: 18 Years and older
Sex: Female

Study 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.

Read the 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

Conditions studied

Irradiation; Adverse Effect
Irradiation Hypothyroidism

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Hypothyroidism 247

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: 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

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 design

Phase: Not applicable
Primary purpose: Other
Allocation: Non-randomized
Intervention model: Factorial assignment
Masking: None (open label)
Enrollment: 500 participants (actual)

Study arms

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 · Radiation: supraclavicular irradiation
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

Interventions

Biologicalbiological sample
T4, thyrotropic-stimulating hormone (TSH) and Thyroglobulin antibody were systematically measured
Radiationsupraclavicular irradiation
Irradiation of the homolateral supraclavicular area delivering 46 Gy in 23 fractions

What researchers measure

Primary outcomes

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.

Study locations

3 sites

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

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT02824016
Lead sponsor: Institut Jean-Godinot
Responsible party: Tan Dat NGUYEN (Professor, Institut Jean-Godinot) — Principal investigator
First posted: Jul 6, 2016
Start date: Feb 2013
Primary completion: Jul 2015
Completion: Jul 2020
Last update: Aug 31, 2021

Study contacts

Yacine MERROUCHE, MD

study director · Institut Jean-Godinot

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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