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
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- HEAD AND NECK CANCER
- Sponsor
- All India Institute of Medical Sciences, New Delhi
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- compare the early tumour response between 3DCRT and IGRT in head and neck cancer.
- Last Updated
- 14 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histopathologically proven cases of Carcinoma Oropharynx,Larynx,Hypopharynx, stages T1-4 N0-2a M0
- •Informed Consent
- •KPS score \> 70
Exclusion Criteria
- •Uncontrolled medical comorbidity
- •Not ready for follow up
- •Previous cancer directed therapy
Outcomes
Primary Outcomes
compare the early tumour response between 3DCRT and IGRT in head and neck cancer.
Time Frame: 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.
Secondary Outcomes
- 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)