Randomized study to protect from radiation iatrogenic hypothyroidism patients with medulloblastoma (any stage, any biological risk) and pediatric patients with Hodgkin lymphoma and non-Hodgkin lymphoma needing radiation therapy on thyroid site - WINHYPO 2021
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Hypothyroidism-free survival at 3 years after radiotherapy including part or the whole thyroid parenchima on the intention-to-treat population will be the main end-point. For both treatment groups (radiotherapy / radiotherapy + Levo-thyroxin), the analysis set will consist of patients evaluated with TSH blood dosage to evaluate the onset of hypothyroidism within three years from the radiotherapy beginning.
研究概览
简要总结
To evaluate if the incidence of hypothyroidism after radiation therapy in medulloblastoma, Hodgkin and non-Hodgkin lymphomas can be reduced by TSH suppression during irradiation.
入排标准
- 年龄范围
- 0 years 至 65+ years（65+ Years, 0-17 Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Any patient with medulloblastoma, Hodgkin/non-Hodgkin Lymphoma BEFORE RADIOTHERAPY (RT) PLANNING INCLUDING THYROID PARENCHYMA without previous primary or secondary hypothyroidism;
- •Written informed consent prior to any study-specific analysis and/or data collection.
排除标准
- •Any patient with medulloblastoma, Hodgkin/non-Hodgkin Lymphoma after radiotherapy including thyroid parenchyma;
- •Not signed consent.
结局指标
主要结局
Hypothyroidism-free survival at 3 years after radiotherapy including part or the whole thyroid parenchima on the intention-to-treat population will be the main end-point. For both treatment groups (radiotherapy / radiotherapy + Levo-thyroxin), the analysis set will consist of patients evaluated with TSH blood dosage to evaluate the onset of hypothyroidism within three years from the radiotherapy beginning.
Hypothyroidism-free survival at 3 years after radiotherapy including part or the whole thyroid parenchima on the intention-to-treat population will be the main end-point. For both treatment groups (radiotherapy / radiotherapy + Levo-thyroxin), the analysis set will consist of patients evaluated with TSH blood dosage to evaluate the onset of hypothyroidism within three years from the radiotherapy beginning.
次要结局
未报告次要终点
研究者
Maura Massimino
Scientific
Fondazione IRCCS Istituto Nazionale Dei Tumori