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
  Purpose

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.

Condition Intervention Phase
Head and Neck Carcinoma
Radiation: VMAT with CBCT
Radiation: VMAT with kV-ray
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility of Volumetric Modulated Arc Therapy and Cone-Beam Computed Tomography for Head and Neck Carinomas: Analysis of Clinical Throughput and Patient Reported Outcomes.

Resource links provided by NLM:


Further study details as provided by British Columbia Cancer Agency:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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)


Enrollment: 20
Study Start Date: July 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VMAT with CBCT
Volumetric modulated arc therapy (VMAT) with cone-beam computed tomography position (CBCT) verification
Radiation: VMAT with CBCT
volumetric modulated arc therapy (VMAT) with cone-beam computed tomography (CBCT) position verification
Active Comparator: VMAT with kV-ray
Volumetric modulation arc therapy (VMAT) with kV-ray position verification
Radiation: VMAT with kV-ray
Volumetric modulated arc therapy (VMAT) with kV-ray position verification

  Eligibility

Ages Eligible for Study:   18 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01384890

Locations
Canada, British Columbia
BC Cancer Agency - Vancouver Centre
Vancouver, British Columbia, Canada, V5Z4E6
Sponsors and Collaborators
British Columbia Cancer Agency
Investigators
Principal Investigator: Jonn Wu, MD British Columbia Cancer Agency
  More Information

No publications provided

Responsible Party: Jonn Wu, Dr. Jonn Wu, British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT01384890     History of Changes
Other Study ID Numbers: VMAT, CBCT for H&N ca
Study First Received: June 28, 2011
Last Updated: February 5, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site

ClinicalTrials.gov processed this record on August 28, 2014