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

This study has been terminated.
(Administratively Terminated by PI)
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00358007
First received: July 27, 2006
Last updated: August 20, 2014
Last verified: August 2014
  Purpose

To evaluate the use of cone beam computed tomography in treating head and neck to hopefully reduce side effects


Condition Intervention Phase
Head and Neck Neoplasms
Device: PTV Reduction
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Evaluation of Cone Beam Kilovoltage Imaging During Radiation Therapy for Tumors of the Head and Neck

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Average Interfraction Shift of Patients Undergoing Radiotherapy [ Time Frame: Daily prior to radiation ] [ Designated as safety issue: No ]

    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 [ Time Frame: Daily after each radiotherapy treatment ] [ Designated as safety issue: No ]
    To determine the magnitude of random variance (random error) in radiotherapy treatment of head and neck neoplasms


Enrollment: 30
Study Start Date: March 2007
Study Completion Date: September 2010
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cone Beam CT Device: PTV Reduction
The margin around the area to be treated with radiation is decreased due the image guidance of the cone beam CT

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT00358007

Locations
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Investigators
Principal Investigator: Pramila Rani Anne, MD Thomas Jefferson University
  More Information

Additional Information:
Publications:
Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00358007     History of Changes
Other Study ID Numbers: 06U.195, 2006-10
Study First Received: July 27, 2006
Results First Received: June 12, 2014
Last Updated: August 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Thomas Jefferson University:
Kilovoltage Imaging
Cone-beam CT
CBCT
radiation therapy
head and neck neoplasms

Additional relevant MeSH terms:
Neoplasms
Head and Neck Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 01, 2014