A Prospective Multicentric Evaluation of the Rate of Incidence of Hypothyroidism After Supraclavicular Irradiation for Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 3
- 主要终点
- Number of patients with treatment-related adverse effects on thyroid function as assessed by CTCAE v4.0
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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
干预措施: biological sample (Biological)
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
干预措施: supraclavicular irradiation (Radiation)
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
干预措施: biological sample (Biological)
结局指标
主要结局
Number of patients with treatment-related adverse effects on thyroid function as assessed by CTCAE v4.0
时间窗: Outcome measures will be assessed every 6 months up to 5 years.
次要结局
未报告次要终点
研究者
Tan Dat NGUYEN
Professor
Institut Jean-Godinot