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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:
ClinicalTrials.gov Identifier:
NCT00358007
First Posted: July 28, 2006
Last Update Posted: November 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )
  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: Intervention Model: Single Group Assignment
Masking: None (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 ( Sidney Kimmel Cancer Center at Thomas Jefferson University ):

Primary Outcome Measures:
  • Average Interfraction Shift of Patients Undergoing Radiotherapy [ Time Frame: Daily prior to radiation ]

    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00358007


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

Additional Information:
Publications:
Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00358007     History of Changes
Other Study ID Numbers: 06U.195
2006-10 ( Other Identifier: CCRRC )
First Submitted: July 27, 2006
First Posted: July 28, 2006
Results First Submitted: June 12, 2014
Results First Posted: August 21, 2014
Last Update Posted: November 29, 2016
Last Verified: October 2016

Keywords provided by Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University ):
Kilovoltage Imaging
Cone-beam CT
CBCT
radiation therapy
head and neck neoplasms

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