This trial is active, not recruiting.

Conditions head and neck cancer, carcinoma oropharynx, carcinoma pyriform sinus, carcinoma larynx
Treatments epid verification, cbct verification
Phase phase 3
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
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.
epid verification EPID
Set up error verification and correction by EPID
(Active Comparator)
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.
cbct verification CBCT
Setup error verification and correction by CBCT

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

Secondary Outcomes

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

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2011.
Information provided to ClinicalTrials.gov by All India Institute of Medical Sciences, New Delhi.