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Feasibility of VMAT and CBCT for Head and Neck Carcinomas

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jonn Wu, British Columbia Cancer Agency
ClinicalTrials.gov Identifier:
NCT01384890
First received: June 28, 2011
Last updated: February 5, 2013
Last verified: February 2013
History of Changes

June 28, 2011
February 5, 2013
July 2011
May 2012   (final data collection date for primary outcome measure)
  • Clinical efficiency for volumetric modulated arc therapy (VMAT) delivery [ Time Frame: After patient treated ] [ Designated as safety issue: No ]
    Prospective work-flow metrics describing clinical efficiency for volumetric modulated arc therapy (VMAT) delivery with and without cone-beam computed tomography (CBCT) acquisition at the BCCA, generated from time requirements for treatment verification and delivery. The time spent by the patients at each stage of radiation therapy delivery will be recorded, including; time in radiation bunker, time in immobilization frame, kV or CBCT acquisition and online correction time, and beam on time
  • Position verification [ Time Frame: After patient treated ] [ Designated as safety issue: No ]
    Summary description of position verification and online corrections for volumetric modulated arch therapy (VMAT) delivery with and without cone-beam computed tomography (CBCT)
  • Clinical efficiency for volumetric modulated arc therapy (VMAT) delivery [ Designated as safety issue: No ]
    Prospective work-flow metrics describing clinical efficiency for volumetric modulated arc therapy (VMAT) delivery with and without cone-beam computed tomography (CBCT) acquisition at the BCCA, generated from time requirements for treatment verification and delivery. The time spent by the patients at each stage of radiation therapy delivery will be recorded, including; time in radiation bunker, time in immobilization frame, kV or CBCT acquisition and online correction time, and beam on time
  • Position verification [ Designated as safety issue: No ]
    Summary description of position verification and online corrections for volumetric modulated arch therapy (VMAT) delivery with and without cone-beam computed tomography (CBCT)
Complete list of historical versions of study NCT01384890 on ClinicalTrials.gov Archive Site
Quality of life [ Time Frame: No time frame (ongoing) ] [ Designated as safety issue: No ]
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Head and Neck Cancer (EORTC QLQ - HN35) (23) (see Appendix V) and State Trait Anxiety Index (STAI)
Quality of life [ Designated as safety issue: No ]
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Head and Neck Cancer (EORTC QLQ - HN35) (23) (see Appendix V) and State Trait Anxiety Index (STAI)
Not Provided
Not Provided
 
Feasibility of VMAT and CBCT for Head and Neck Carcinomas
Feasibility of Volumetric Modulated Arc Therapy and Cone-Beam Computed Tomography for Head and Neck Carinomas: Analysis of Clinical Throughput and Patient Reported Outcomes.

This will be a prospective longitudinal study describing clinical throughput metrics and patient reported quality of life outcome measures for patients undergoing Volumetric modulated arc therapy (VMAT) with and without Cone-beam computed tomography (CBCT) for head and neck carcinoma at the British Columbia Cancer Agency.

  1. VMAT for the treatment of patients with HNC will provide opportunities for image-guided radiotherapy using CBCT online correction to reduce systematic and random error.
  2. Analysis of patient reported quality of life outcomes during VMAT, with and without CBCT acquisition, will be hypothesis generating.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Head and Neck Carcinoma
  • Radiation: VMAT with CBCT
    volumetric modulated arc therapy (VMAT) with cone-beam computed tomography (CBCT) position verification
  • Radiation: VMAT with kV-ray
    Volumetric modulated arc therapy (VMAT) with kV-ray position verification
  • Experimental: VMAT with CBCT
    Volumetric modulated arc therapy (VMAT) with cone-beam computed tomography position (CBCT) verification
    Intervention: Radiation: VMAT with CBCT
  • Active Comparator: VMAT with kV-ray
    Volumetric modulation arc therapy (VMAT) with kV-ray position verification
    Intervention: Radiation: VMAT with kV-ray
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
May 2012
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • age greater than 18 years
  • undergoing radical radiation therapy for head and neck carcinoma at the BC Cancer Agency

Exclusion Criteria:

  • treatment being offered is not for curative intent
  • patient has received previous radiation for head and neck cancer
  • patient has systemic lupus erythematosis or scleroderma
  • patients has other autoimmune connective tissue disorders
Both
18 Months and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01384890
VMAT, CBCT for H&N ca
No
Jonn Wu, British Columbia Cancer Agency
British Columbia Cancer Agency
Not Provided
Principal Investigator: Jonn Wu, MD British Columbia Cancer Agency
British Columbia Cancer Agency
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP