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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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HEAD AND NECK CANCER, CARCINOMA OROPHARYNX, CARCINOMA PYRIFORM SINUS, CARCINOMA LARYNX

Intervention / Treatment
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* Radiation: EPID Verification
* Radiation: CBCT verification


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 3DCRT with EPID<br>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. | Radiation: EPID Verification<br>* Set up error verification and correction by EPID<br>* Other names: HNSCC;|
| Active Comparator: IGRT with CBCT<br>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. | Radiation: CBCT verification<br>* Setup error verification and correction by CBCT<br>* Other names: HNSCC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess and compare early and late toxicities between 3DCRT and IGRT in head and neck cancer | Assessment will be done by RTOG scoring criteria | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IGRT, 3DCRT, EPID, CBCT, HNSCC