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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-A00822-39 | Other Identifier | RCB identifier (ANSM) | |
| 2013-A00755-40 | Other Identifier | RCB identifier (ANSM) |
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Prospective, multicentric, comparative, non randomised, in current care.
Primary objective:
Secondary objectives :
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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biological sample | Biological | T4, thyrotropic-stimulating hormone (TSH) and Thyroglobulin antibody were systematically measured |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yacine MERROUCHE, MD | Institut Jean-Godinot | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Jean Godinot | Reims | 51100 | France | |||
| Centre Paul Strauss |
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| supraclavicular irradiation | Radiation | Irradiation of the homolateral supraclavicular area delivering 46 Gy in 23 fractions |
|
| Strasbourg |
| 67000 |
| France |
| Institut de Cancerologie de Lorraine | Vandœuvre-lès-Nancy | 54519 | France |