Phase II Randomized Controlled Trial Of Postoperative Intensity Modulated Radiotherapy (IMRT) in Locally Advanced Thyroid Cancers.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- locoregional recurrence
研究概览
简要总结
This trial deals with cancers of the thyroid gland which are advanced at the local site of thyroid. These cancers are treated with surgery and complete removal of the thyroid gland. But due to advanced nature, there is risk of re-occurrence. Radiotherapy can be used to prevent this re-occurrence. This study attempt to see the effect of radiotherapy in preventing re-occurrence and its side effects in advanced thyroid cancer.
详细描述
Surgery, when possible offers the best chance of cure for cancer of the thyroid gland. Surgery for thyroid cancer involves removal of the thyroid gland along with removal of the lymph nodes which drain the gland. After surgery most patients will receive radio-iodine treatment to diagnose and treat any spread of the cancer in the body. Most thyroid cancers will have good outcomes with the above mentioned treatment. However, in advanced thyroid cancer there is a higher chance of recurrence even with surgery and radio iodine. Surgery for recurrence of these cancers is very morbid This may entail surgeries which may also involve removing portions of the voice box and food pipe. You may therefore develop and discomfort or inability to eat or speak.
Radiation therapy can be given to the neck along with radio-iodine therapy to decrease these re occurrences of the cancer. A number of studies have shown a benefit with the use of radiation therapy in advanced cases of thyroid cancer. However, the side effects of radiation, if any, have not been well documented. This study is being done to assess the impact of radiation on the outcome of cancer and the exact side effects of radiation therapy. If the side effects are not too many, then radiation therapy can be used to decrease the chances of recurrence in the neck after thyroid.
In this study, patients undergoing total thyroidectomy for thyroid cancer will be assessed for high risk features on the histopathology report and the intra operative findings. Those with advanced thyroid cancer as per the eligibility criteria will be counselled and consented for the study. Those patients willing to participate in the study will be randomised to either receive only surgery and radio-iodine or surgery, radio-iodine and external beam radiation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A) All patients of differentiated thyroid cancer (papillary/follicular/poorly differentiated/) who have undergone total/completion thyroidectomy at our institute and having at least two of the following features (listed below) intra-operatively and/or on histopathology
- •Gross extrathyroidal spread into soft tissues of the neck, trachea, esophagus, recurrent laryngeal nerve (constituting stage T4a)
- •R1/ shave resections (minimal residual disease)
- •R2 resections (gross residual disease)
- •Multiple lymph nodes positive(>2) with perinodal extension at level VI B) Normal baseline haematological and biochemical parameters.
排除标准
- •Anaplastic or medullary thyroid cancer
- •Previous history of radiation
- •< 18 years Patient unwilling to participate in the study.
结局指标
主要结局
locoregional recurrence
时间窗: after completion of treatment- till 5 years
locoregional recurrence is defined as occurrence of pathology proven recurrence in the neck
次要结局
- acute toxicity(during treatment- till 23 months)
- late toxicity(at 2 years after treatment completion)
研究者
Dr. Gouri Pantvaidya
Associate Professor & Assistant surgeon E
Tata Memorial Hospital