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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by All India Institute of Medical Sciences, New Delhi.
Recruitment status was  Active, not recruiting
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
  Purpose

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.


Condition Intervention Phase
HEAD AND NECK CANCER
CARCINOMA OROPHARYNX
CARCINOMA PYRIFORM SINUS
CARCINOMA LARYNX
Radiation: EPID Verification
Radiation: CBCT verification
Phase 3

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

Resource links provided by NLM:


Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 41
Study Start Date: December 2009
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • CBCT
  • IGRT
  • HNSCC

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01124409

Locations
India
All India Institute of Medical Sciences
New Delhi, India, 110029
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Investigators
Study Chair: BIDHU K MOHANTI, MD All India Institute of Medical Sciences, New Delhi
  More Information

No publications provided

Responsible Party: DR.SUJITH KUMAR MULLAPALLY, ALL INDIA INSTITUTE OF MEDICAL SCIENCES
ClinicalTrials.gov Identifier: NCT01124409     History of Changes
Other Study ID Numbers: 3DIGHNC
Study First Received: May 13, 2010
Last Updated: June 21, 2011
Health Authority: India: Institutional Review Board

Keywords provided by All India Institute of Medical Sciences, New Delhi:
IGRT
3DCRT
EPID
CBCT
HNSCC

Additional relevant MeSH terms:
Carcinoma
Head and Neck Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on October 30, 2014