Pilot study to evaluate the feasibility of thyroid sparing Volumetric Modulated Arc Radiotherapy in the management of locally advanced head and neck cancers.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 1. To study the feasibility of achieving the dose volume constraints to the thyroid gland using Volumetric modulated arc radiotherapy (VMAT) technique.
研究概览
简要总结
The thyroid gland receives a significant and unintended dose of radiation during the treatment of head and neck malignancies which leads to hypothyroidism. Both clinical and subclinical hypothyroidism is known to occur after head and neck radiotherapy which would add on to the existing morbidity of these patients with malignancy. With newer conformal techniques of radiotherapy like Volumetric Modulated Arc radiotherapy (VMAT) it is possible to precisely deliver radiation to the disease volume while sparing the organs at risk. Recent literature has suggested possible dose volume constraints to the thyroid gland which when achieved may reduce the incidence of hypothyroidism.
This study will evaluate if effective thyroid sparing can be achieved using Simultaneous Integrated Boost Radiotherapy in head and neck cancers without compromising the coverage of nodal areas. This has the potential to reduce radiation induced Hypothyroidism and its associated co morbidities in head and neck cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Squamous cell carcinoma of the oral cavity, oropharynx, supraglottic larynx and hypopharynx 2 Locally advanced disease (Stage III , IV) 3 Histological proof of malignancy 4 Patients treated with radical intent.
排除标准
- •Patients with Nasopharyngeal malignancies
- •Patients who have thyroid dysfunction or are known to have thyroid dysfunction during baseline investigations
- •Prior radiotherapy, chemotherapy or head and neck surgery 4.Thyroid malignancies or tumours involving the thyroid gland.
结局指标
主要结局
1. To study the feasibility of achieving the dose volume constraints to the thyroid gland using Volumetric modulated arc radiotherapy (VMAT) technique.
时间窗: Study duration is for 2 years with a sample size of 20 patients
2. To evaluate the Dose volume histogram(DVH) coverage of Clinical target volume(CTV) and Planning target volume (PTV) nodal volumes with and without thyroid sparing radiotherapy techniques.
时间窗: Study duration is for 2 years with a sample size of 20 patients
次要结局
- 1. To evaluate the thyroid profile at the end of radiotherapy , 6 months and 12 months for the two study arms.(2. To evaluate the progression free survival at last follow up in both the study arms.)