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

Head and Neck Neoplasms Clinical Trial

Official title:

Evaluation of Cone Beam Kilovoltage Imaging During Radiation Therapy for Tumors of the Head and Neck

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00358007
• Other study ID #: 06U.195
• Secondary ID: 2006-10
• Status: Terminated
• Phase: Phase 2
• First received: July 27, 2006
• Last updated: August 20, 2014
• Start date: March 2007
• Est. completion date: September 2010

Study information

• Verified date: August 2014
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: September 2010
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• any patient receiving radiation therapy for a head and neck tumor assigned to the new Elekta Synergy Linare Accelerator

Exclusion Criteria:

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Head and Neck Neoplasms

Intervention

Device:
• PTV Reduction
The margin around the area to be treated with radiation is decreased due the image guidance of the cone beam CT

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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; — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Daily prior to radiation	No
Primary	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	Daily after each radiotherapy treatment	No

External Links

•   Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center