Randomised Clinical Phase III Study of Radiotherapy Dose, Volume Evaluation for 3DCRT Versus IGRT and Analysis of Early Response in Head and Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- compare the early tumour response between 3DCRT and IGRT in head and neck cancer.
研究概览
简要总结
This study aims to study the impact image guided radiotherapy with Cone beam CT will have on the outcomes(toxicities and response) of head and neck cancer when compared to 3D conformal radiotherapy without CBCT based setup error verification.Also,the various dosimetric variations in Adaptive RT will be studied.
详细描述
Aims and Objectives
- To assess the patient's radiation dose planning for GTV, CTV and PTV for primary and nodal regions and derive comparison between IGRT and 3D-CRT.
- To assess the dosimetric variation in different phases of adaptive RT due to changes in tumor shape and volume during the course of entire treatment in IGRT arm in head and neck cancer patients.
- To evaluate the optimal setup correction methodology using planar (EPID) and volumetric images (CBCT) in HNSCC between 3D-CRT and IGRT treatment delivery respectively.
- To compare the early tumour response and acute and chronic radiation morbidities between IGRT and 3D-CRT.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histopathologically proven cases of Carcinoma Oropharynx,Larynx,Hypopharynx, stages T1-4 N0-2a M0
- •Informed Consent
- •KPS score > 70
排除标准
- •Uncontrolled medical comorbidity
- •Not ready for follow up
- •Previous cancer directed therapy
结局指标
主要结局
compare the early tumour response between 3DCRT and IGRT in head and neck cancer.
时间窗: Assessment at post RT week, 1 month after completion of RT and 6 month after completion of RT. Final assessment of last recruited patient is anticipated to be by AUGUST 2011
The advent of CBCT has increased the verification of Radiation treatment delivery but whether it leads to significant change in tumour response or toxicities when compared to 3D Conformal Radiotherapy without CBCT verification is not known.This study will give insights into this question.
次要结局
- To assess and compare early and late toxicities between 3DCRT and IGRT in head and neck cancer(assessment of acute and chronic toxicities of the last recruited patient anticipated to be by March 2011)
- To find out the different doses received by target and organs at risk during the various phases of adaptive RT.(last measurement by AUG 2011)