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

Primary Purpose

HEAD AND NECK CANCER, CARCINOMA OROPHARYNX, CARCINOMA PYRIFORM SINUS

Status
Unknown status
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
EPID Verification
CBCT verification
Sponsored by
All India Institute of Medical Sciences, New Delhi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HEAD AND NECK CANCER focused on measuring IGRT, 3DCRT, EPID, CBCT, HNSCC

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • All India Institute of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

3DCRT with EPID

IGRT with CBCT

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
To find out the different doses received by target and organs at risk during the various phases of adaptive RT.

Full Information

First Posted
May 13, 2010
Last Updated
June 21, 2011
Sponsor
All India Institute of Medical Sciences, New Delhi
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1. Study Identification

Unique Protocol Identification Number
NCT01124409
Brief Title
Evaluation of 3DCRT Versus IGRT and Analysis of Early Response in Head and Neck Cancer.
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Unknown status
Study Start Date
December 2009 (undefined)
Primary Completion Date
August 2011 (Anticipated)
Study Completion Date
August 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
All India Institute of Medical Sciences, New Delhi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
Aims and Objectives 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. 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. To evaluate the optimal setup correction methodology using planar (EPID) and volumetric images (CBCT) in HNSCC between 3D-CRT and IGRT treatment delivery respectively. To compare the early tumour response and acute and chronic radiation morbidities between IGRT and 3D-CRT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HEAD AND NECK CANCER, CARCINOMA OROPHARYNX, CARCINOMA PYRIFORM SINUS, CARCINOMA LARYNX
Keywords
IGRT, 3DCRT, EPID, CBCT, HNSCC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3DCRT with EPID
Arm Type
Active Comparator
Arm Description
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.
Arm Title
IGRT with CBCT
Arm Type
Active Comparator
Arm Description
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 Type
Radiation
Intervention Name(s)
EPID Verification
Other Intervention Name(s)
EPID, 3DCRT, HNSCC
Intervention Description
Set up error verification and correction by EPID
Intervention Type
Radiation
Intervention Name(s)
CBCT verification
Other Intervention Name(s)
CBCT, IGRT, HNSCC
Intervention Description
Setup error verification and correction by CBCT
Primary Outcome Measure Information:
Title
compare the early tumour response between 3DCRT and IGRT in head and neck cancer.
Description
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.
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 Outcome Measure Information:
Title
To assess and compare early and late toxicities between 3DCRT and IGRT in head and neck cancer
Description
Assessment will be done by RTOG scoring criteria
Time Frame
assessment of acute and chronic toxicities of the last recruited patient anticipated to be by March 2011
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BIDHU K MOHANTI, MD
Organizational Affiliation
All India Institute of Medical Sciences, New Delhi
Official's Role
Study Chair
Facility Information:
Facility Name
All India Institute of Medical Sciences
City
New Delhi
ZIP/Postal Code
110029
Country
India

12. IPD Sharing Statement

Learn more about this trial

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

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