Clinical trial NCT02824016: Evaluation of Hypothyroidism Incidence After Breast Cancer Supraclavicular Irradiation
Official title: A Prospective Multicentric Evaluation of the Rate of Incidence of Hypothyroidism After Supraclavicular Irradiation for Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irradiation; Adverse Effect
Irradiation Hypothyroidism
Lead sponsor: Institut Jean-Godinot
Sponsor class: OTHER
First posted: 2016-07-06
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

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

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

Primary outcomes:
measure: Number of patients with treatment-related adverse effects on thyroid function as assessed by CTCAE v4.0
timeFrame: Outcome measures will be assessed every 6 months up to 5 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Institut Jean Godinot
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Vandoeuvre-les-nancy
country: France
facility: Institut de Cancerologie de Lorraine
Study officials:
affiliation: Institut Jean-Godinot
name: Yacine MERROUCHE, MD
role: STUDY_DIRECTOR
References: