Evaluation of 3DCRT Versus IGRT and Analysis of Early Response in Head and Neck Cancer.
This trial is active, not recruiting.
|Conditions||head and neck cancer, carcinoma oropharynx, carcinoma pyriform sinus, carcinoma larynx|
|Treatments||epid verification, cbct verification|
|Sponsor||All India Institute of Medical Sciences, New Delhi|
|Start date||December 2009|
|End date||August 2011|
|Trial size||41 participants|
|Trial identifier||NCT01124409, 3DIGHNC|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
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
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
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
Male or female participants from 18 years up to 65 years old.
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
|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|
|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.|
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