ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02824016
Recruitment Status : Active, not recruiting
First Posted : July 6, 2016
Last Update Posted : August 24, 2017
Sponsor:
Information provided by (Responsible Party):
Tan Dat NGUYEN, Institut Jean-Godinot

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 Not Applicable

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  (Clinical Trial)
Estimated 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 : February 2013
Actual Primary Completion Date : July 2015
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothyroidism

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




Primary Outcome Measures :
  1. 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. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824016


Locations
France
Institut Jean Godinot
Reims, France, 51100
Centre Paul Strauss
Strasbourg, France, 67000
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

Responsible Party: Tan Dat NGUYEN, Professor, Institut Jean-Godinot
ClinicalTrials.gov Identifier: NCT02824016     History of Changes
Other Study ID Numbers: 2013-A00755-40
2011-A00822-39 ( Other Identifier: RCB identifier (ANSM) )
2013-A00755-40 ( Other Identifier: RCB identifier (ANSM) )
First Posted: July 6, 2016    Key Record Dates
Last Update Posted: August 24, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Hypothyroidism
Thyroid Diseases
Endocrine System Diseases