search
Back to results

Use of Cone Beam Kilovoltage Imaging in Patients Receiving Radiation Therapy for Head and Neck Cancer

Primary Purpose

Head and Neck Neoplasms

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PTV Reduction
Sponsored by
Sidney Kimmel Cancer Center at Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Neoplasms focused on measuring Kilovoltage Imaging, Cone-beam CT, CBCT, radiation therapy, head and neck neoplasms

Eligibility Criteria

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

Inclusion Criteria: any patient receiving radiation therapy for a head and neck tumor assigned to the new Elekta Synergy Linare Accelerator Exclusion Criteria: NA

Sites / Locations

  • Thomas Jefferson University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cone Beam CT

Arm Description

Outcomes

Primary Outcome Measures

Average Interfraction Shift of Patients Undergoing Radiotherapy
Determine the magnitude of the systematic error of patient positioning as determined by cone beam CT (CBCT) and the desired placement based on the treatment planning CT scan. Every day, prior to radiation treatment, a CBCT will be performed. The CBCT images will be compared to the radiation therapy planning CT image just taken.
Average Residual Error Motion of Patients Undergoing Radiotherapy
To determine the magnitude of random variance (random error) in radiotherapy treatment of head and neck neoplasms

Secondary Outcome Measures

Full Information

First Posted
July 27, 2006
Last Updated
October 19, 2016
Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
search

1. Study Identification

Unique Protocol Identification Number
NCT00358007
Brief Title
Use of Cone Beam Kilovoltage Imaging in Patients Receiving Radiation Therapy for Head and Neck Cancer
Official Title
Evaluation of Cone Beam Kilovoltage Imaging During Radiation Therapy for Tumors of the Head and Neck
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Why Stopped
Administratively Terminated by PI
Study Start Date
March 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate the use of cone beam computed tomography in treating head and neck to hopefully reduce side effects
Detailed Description
The general purpose of this study is to evaluate Kilovoltage (kv) Imaging, specifically the Cone-beam CT (CBCT) scan device, to assess the accuracy of radiation therapy treatment delivery for patients with head and neck neoplasms

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasms
Keywords
Kilovoltage Imaging, Cone-beam CT, CBCT, radiation therapy, head and neck neoplasms

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cone Beam CT
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
PTV Reduction
Intervention Description
The margin around the area to be treated with radiation is decreased due the image guidance of the cone beam CT
Primary Outcome Measure Information:
Title
Average Interfraction Shift of Patients Undergoing Radiotherapy
Description
Determine the magnitude of the systematic error of patient positioning as determined by cone beam CT (CBCT) and the desired placement based on the treatment planning CT scan. Every day, prior to radiation treatment, a CBCT will be performed. The CBCT images will be compared to the radiation therapy planning CT image just taken.
Time Frame
Daily prior to radiation
Title
Average Residual Error Motion of Patients Undergoing Radiotherapy
Description
To determine the magnitude of random variance (random error) in radiotherapy treatment of head and neck neoplasms
Time Frame
Daily after each radiotherapy treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: any patient receiving radiation therapy for a head and neck tumor assigned to the new Elekta Synergy Linare Accelerator Exclusion Criteria: NA
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pramila Rani Anne, MD
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19540071
Citation
Den RB, Doemer A, Kubicek G, Bednarz G, Galvin JM, Keane WM, Xiao Y, Machtay M. Daily image guidance with cone-beam computed tomography for head-and-neck cancer intensity-modulated radiotherapy: a prospective study. Int J Radiat Oncol Biol Phys. 2010 Apr;76(5):1353-9. doi: 10.1016/j.ijrobp.2009.03.059. Epub 2009 Jun 18.
Results Reference
result

Learn more about this trial

Use of Cone Beam Kilovoltage Imaging in Patients Receiving Radiation Therapy for Head and Neck Cancer

We'll reach out to this number within 24 hrs