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NCT01124409 Clinical Trial

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

HEAD AND NECK CANCER Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01124409
Other study ID # 3DIGHNC
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received May 13, 2010
Last updated June 21, 2011
Start date December 2009
Est. completion date August 2011

Study information
Verified date June 2011
Source All India Institute of Medical Sciences, New Delhi
Contact n/a
Is FDA regulated No
Health authority India: Institutional Review Board
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 41
Est. completion date August 2011
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Radiation:
• EPID Verification
Set up error verification and correction by EPID
• CBCT verification
Setup error verification and correction by CBCT

Locations
Country Name City State
India All India Institute of Medical Sciences New Delhi

Sponsors (1)
Lead Sponsor Collaborator
All India Institute of Medical Sciences, New Delhi

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
Secondary 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 No
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