Irradiation; Adverse EffectEPITHERMNCT02824016
Evaluation of Hypothyroidism Incidence After Breast Cancer Supraclavicular Irradiation
A study testing biological sample and supraclavicular irradiation in people with Irradiation; Adverse Effect and Irradiation Hypothyroidism, run by Institut Jean-Godinot at 3 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Irradiation; Adverse Effect, Irradiation Hypothyroidism
- What is being tested?
- biological sample and supraclavicular irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 3 sitesFrance
- Study dates
- Feb 2013to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Institut Jean Godinot
Reims, 51100
Centre Paul Strauss
Strasbourg, 67000
Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy, 54519
About this study
Official title: A Prospective Multicentric Evaluation of the Rate of Incidence of Hypothyroidism After Supraclavicular Irradiation for Breast Cancer
Prospective, multicentric, comparative, non randomised, in current care.
Primary objective:
Read more
- 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
- Being tested
- biological sample, supraclavicular irradiation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biological sampleBiological
T4, thyrotropic-stimulating hormone (TSH) and Thyroglobulin antibody were systematically measured
supraclavicular irradiationRadiation
Irradiation of the homolateral supraclavicular area delivering 46 Gy in 23 fractions
| Study group | Role | What they receive |
|---|---|---|
| with supraclavicular irradiation | Active comparator | Patients received supraclavicular irradiation according to local policies. Biological samples were obtained in order to evaluate hypothyroidism during the follow-up period Receives: Biological: biological sample; Radiation: supraclavicular irradiation |
| without supraclavicular irradiation | Active comparator | Patients did not receive supraclavicular irradiation according to local policies. Biological samples were obtained in order to evaluate hypothyroidism during the follow-up period Receives: Biological: biological sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with treatment-related adverse effects on thyroid function as assessed by CTCAE v4.0
Measured: Outcome measures will be assessed every 6 months up to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study startFeb 2013
- Primary completionJul 2015
- Study completionJul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irradiation; Adverse EffectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Jean-Godinot
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tan Dat NGUYEN, Institut Jean-Godinot
- Investigators
- Yacine MERROUCHE, MD, Study director, Institut Jean-Godinot
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02824016
- Sponsor's protocol ID
- 2013-A00755-40
- Other IDs
- 2011-A00822-39, 2013-A00755-40
- Acronym
- EPITHERM
- Status last verified
- Aug 2021
- First submitted
- 25 Aug 2014
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicentric Evaluation of the Rate of Incidence of Hypothyroidism After Supraclavicular Irradiation for Breast Cancer
- ClinicalTrials.gov ID
- NCT02824016
- Acronym / sponsor ID
- EPITHERM / 2013-A00755-40
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Institut Jean-GodinotUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 6 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with supraclavicular irradiation | Active comparator | Biological: biological sample, Radiation: supraclavicular irradiationPatients received supraclavicular irradiation according to local policies. Biological samples were obtained in order to evaluate hypothyroidism during the follow-up period |
| without supraclavicular irradiation | Active comparator | Biological: biological samplePatients did not receive supraclavicular irradiation according to local policies. Biological samples were obtained in order to evaluate hypothyroidism during the follow-up period |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biological sampleT4, thyrotropic-stimulating hormone (TSH) and Thyroglobulin antibody were systematically measured | Biological | with supraclavicular irradiation, without supraclavicular irradiation |
| supraclavicular irradiationIrradiation of the homolateral supraclavicular area delivering 46 Gy in 23 fractions | Radiation | with supraclavicular irradiation |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Irradiation; Adverse Effect
Not yet recruitingPhase 2
The CARDIOPROTECT Trial
Diffuse Large B-cell Lymphoma (DLBCL), Cardiotoxicity
RecruitingObservational study
3D Versus 2D Strain Echocardiography for Early Detection of Cardiotoxicity During Cancer Therapy
Cancer Related Cardiovascular Toxicity, Anthracycline Related Cardiotoxicity in Breast Cancer
Not yet recruitingPhase 2
The Impact of Using Nicorandil for the Prevention of Doxorubicin-Induced Cardiotoxicity
Doxorubicin Induced Cardiotoxicity, Doxorubicin Induced Cardiomyopathy
Not yet recruitingObservational study
PAtient Similarity for Decision-Making in Prevention of Cardiovascular Toxicity (PACT): A Feasibility Study
Heart Failure, Coronary Artery Disease
Not yet recruiting
Monitoring for CardioToxicity Using WeArable deVices While Undergoing cancEr Treatments (MCT-WAVE)
Cardiotoxicity, Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yacine MERROUCHE, MD study director
Institut Jean-Godinot
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biological sample and supraclavicular irradiation in people with Irradiation; Adverse Effect and Irradiation Hypothyroidism, run by Institut Jean-Godinot at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2021.