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OpenTrials
Completed

NCT Number: NCT01384890

Feasibility of VMAT and CBCT for Head and Neck Carcinomas

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.

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Key information

Conditions

Head and Neck Carcinoma

Age range

18 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

BC Cancer Agency - Vancouver Centre

Vancouver, British Columbia, V5Z4E6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VMAT with CBCT

Radiation

volumetric modulated arc therapy (VMAT) with cone-beam computed tomography (CBCT) position verification

VMAT with kV-ray

Radiation

Volumetric modulated arc therapy (VMAT) with kV-ray position verification

Primary outcomes

  1. Clinical efficiency for volumetric modulated arc therapy (VMAT) delivery

    Time frame: After patient treated

    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

  2. Position verification

    Time frame: After patient treated

    Summary description of position verification and online corrections for volumetric modulated arch therapy (VMAT) delivery with and without cone-beam computed tomography (CBCT)

Secondary outcomes

  1. Quality of life

    Time frame: No time frame (ongoing)

    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)

Sponsors and collaborators

Lead sponsor

British Columbia Cancer Agency

Other

Registry information

Official study 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.

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 29, 2011
Registry last updated
Feb 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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