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

June 21, 2011 updated by: All India Institute of Medical Sciences, New Delhi

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • New Delhi, India, 110029
        • All India Institute of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Other Names:
  • EPID
  • 3DCRT
  • HNSCC
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
Other Names:
  • IGRT
  • HNSCC
  • CBCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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
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
last measurement by AUG 2011

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

All India Institute of Medical Sciences, New Delhi

Investigators

  • Study Chair: BIDHU K MOHANTI, MD, All India Institute of Medical Sciences, New Delhi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Anticipated)

August 1, 2011

Study Completion (Anticipated)

August 1, 2011

Study Registration Dates

First Submitted

May 13, 2010

First Submitted That Met QC Criteria

May 14, 2010

First Posted (Estimate)

May 17, 2010

Study Record Updates

Last Update Posted (Estimate)

June 23, 2011

Last Update Submitted That Met QC Criteria

June 21, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3DIGHNC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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