Evaluation of 3DCRT Versus IGRT and Analysis of Early Response in Head and Neck Cancer.

Phase 3

• Conditions: HEAD AND NECK CANCER; CARCINOMA OROPHARYNX; CARCINOMA PYRIFORM SINUS; CARCINOMA LARYNX
• Interventions: Radiation: EPID Verification; Radiation: CBCT verification

• Registration Number: NCT01124409
• Lead Sponsor: All India Institute of Medical Sciences, New Delhi

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.

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-05-13
• Study First Submitted QC: 2010-05-14
• Study First Posted: 2010-05-17
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-21
• Last Update Posted: 2011-06-23
• Primary Completion: 2011-08
• Study Completion: 2011-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3DCRT with EPID	EPID Verification	this patients randomised to this arm will be planned by 3DCRT and during treatment setup error will be identified and corrected by weekly EPID if error \>3mm.Weekly CBCT will be done for this arm to note the setup error but will not be corrected.
IGRT with CBCT	CBCT verification	The patients randomised to this arm will be planned by 3DCRT and set up error during RT will be verified by CBCT and error corrected if \>3mm.Weekly EPID will be done for setup error documentation but no correction based on EPID in this arm.

Primary Outcome Measures

Name	Time	Method
compare the early tumour response between 3DCRT and IGRT in head and neck cancer.	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 Outcome Measures

Name	Time	Method
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	Assessment will be done by RTOG scoring criteria
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

Trial Locations

Locations (1)

All India Institute of Medical Sciences; 🇮🇳 New Delhi, India