跳至主要内容
临床试验/CTRI/2018/01/011637
CTRI/2018/01/011637尚未招募不适用

Adaptive Radiotherapy in Head and Neck Cancers-A Prospective Study

CSIR1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年5月2日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
CSIR
入组人数
30
试验地点
1
主要终点
2.To assess acute and chronic toxicities of treatment.

研究概览

简要总结

Head and neck cancers (HNC) constitute one of the most common cancers in the developing world. In a recent study from India, of approximately 556,400 cancer deaths in the year 2010, the most fatal cancers were HNC. Radiotherapy plays a central role in treatment of locally advanced head and neck cancers (LAHNC). Over the years, the delivery of radiation therapy has improved with innovations that have reduced toxicity without compromis­ing loco-regional control. Among these advances, the development of intensity-modulated radiation therapy (IMRT) has represented a major turning point in the treatment of HNC patients.

Several factors may result in set-up uncertainties and a potentially decreased therapeutic ratio such as patient repositioning on the treatment table, weight loss, tumor and lymph node shrinkage, tissue swelling and lymphedema, and alteration of fat distribution.   More recently, image guidance has been used for adaptive radiotherapy (ART) — the adjustment of treatment planning dur­ing the course of radiation to account for anatomic changes and improves the thera­peutic index.

Why is ART necessary?

In literature, some studies have reported volumetric changes during adaptive planning. Barker et al  have reported a median GTV reduction at a rate of 0.2 cm3 per day, corresponding to a 70% reduction on the last day of RT.

ART is conceptually an attractive approach to account for and correct tumour and normal tissue variations during treatment, but at present, there are limited data to guide its clinical application in day-to-day practice. This study will help in designing institutional protocol and will give useful scientific data for further studies.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • •Age > 18 years Histologically proven squamous cell carcinoma Written informed consent Locally advanced head and neck cancers.

排除标准

  • •1.Resection of primary tumor 2.Delivery of induction chemotherapy prio to radiation 3.Prior history of malignancy 4.History of prior radiation 5.KPS <70.

结局指标

主要结局

2.To assess acute and chronic toxicities of treatment.

时间窗: weekly during treatment then at 1 month, 3 monthly for 2 years and 6 monthly for 5 years

To assess local control and survival

时间窗: weekly during treatment then at 1 month, 3 monthly for 2 years and 6 monthly for 5 years

Primary outcome

时间窗: weekly during treatment then at 1 month, 3 monthly for 2 years and 6 monthly for 5 years

To evaluate the dosimetric changes in PTV and organs at risk during adaptive radiotherapy.

时间窗: weekly during treatment then at 1 month, 3 monthly for 2 years and 6 monthly for 5 years

Secondary Outcome

时间窗: weekly during treatment then at 1 month, 3 monthly for 2 years and 6 monthly for 5 years

次要结局

  • Primary outcome(To evaluate the dosimetric changes in PTV and organs at risk during adaptive radiotherapy.)
  • To assess local control and survival

研究者

发起方
CSIR
申办方类型
Research institution

研究点 (1)

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