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
Aims and Objectives
1. 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.
2. 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.
3. To evaluate the optimal setup correction methodology using planar (EPID) and volumetric
images (CBCT) in HNSCC between 3D-CRT and IGRT treatment delivery respectively.
4. To compare the early tumour response and acute and chronic radiation morbidities
between IGRT and 3D-CRT.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
compare the early tumour response between 3DCRT and IGRT in head and neck cancer.
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.
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
BIDHU K MOHANTI, MD
All India Institute of Medical Sciences, New Delhi
India: Institutional Review Board