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: April 7, 2014
Last verified: April 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:
  • The hypothesis is that by using CBCT, the CTV to PTV margin can be reduced by approximately 50% (from 5 mm to 2.5 mm) and that this can reduce toxicity and allow radiotherapy dose escalation. [ Designated as safety issue: No ]

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
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
Last Updated: April 7, 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 April 17, 2014