Evaluation of 3DCRT Versus IGRT and Analysis of Early Response in Head and Neck Cancer.
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|ClinicalTrials.gov Identifier: NCT01124409|
Recruitment Status : Unknown
Verified June 2011 by All India Institute of Medical Sciences, New Delhi.
Recruitment status was: Active, not recruiting
First Posted : May 17, 2010
Last Update Posted : June 23, 2011
|Condition or disease||Intervention/treatment||Phase|
|HEAD AND NECK CANCER CARCINOMA OROPHARYNX CARCINOMA PYRIFORM SINUS CARCINOMA LARYNX||Radiation: EPID Verification Radiation: CBCT verification||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||December 2009|
|Estimated Primary Completion Date :||August 2011|
|Estimated Study Completion Date :||August 2011|
Active Comparator: 3DCRT with EPID
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
Set up error verification and correction by EPID
Active Comparator: IGRT with CBCT
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
Setup error verification and correction by CBCT
- 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.
- To assess and compare early and late toxicities between 3DCRT and IGRT in head and neck cancer [ Time Frame: 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. [ Time Frame: last measurement by AUG 2011 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01124409
|All India Institute of Medical Sciences|
|New Delhi, India, 110029|
|Study Chair:||BIDHU K MOHANTI, MD||All India Institute of Medical Sciences, New Delhi|