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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT01124409
First received: May 13, 2010
Last updated: June 21, 2011
Last verified: June 2011
History of Changes

May 13, 2010
June 21, 2011
December 2009
August 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
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 March 2011 ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT01124409 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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 Oct 2010 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Evaluation of 3DCRT Versus IGRT and Analysis of Early Response in Head and Neck Cancer.
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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HEAD AND NECK CANCER
  • CARCINOMA OROPHARYNX
  • CARCINOMA PYRIFORM SINUS
  • CARCINOMA LARYNX
  • Radiation: EPID Verification
    Set up error verification and correction by EPID
    Other Names:
    • EPID
    • 3DCRT
    • HNSCC
  • Radiation: CBCT verification
    Setup error verification and correction by CBCT
    Other Names:
    • CBCT
    • IGRT
    • HNSCC
  • 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.
    Intervention: Radiation: EPID Verification
  • 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.
    Intervention: Radiation: CBCT verification
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
41
August 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01124409
3DIGHNC
Yes
DR.SUJITH KUMAR MULLAPALLY, ALL INDIA INSTITUTE OF MEDICAL SCIENCES
All India Institute of Medical Sciences, New Delhi
Not Provided
Study Chair: BIDHU K MOHANTI, MD All India Institute of Medical Sciences, New Delhi
All India Institute of Medical Sciences, New Delhi
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP