Feasibility of VMAT and CBCT for Head and Neck Carcinomas

Study Overview
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Brief Summary
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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. 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. Analysis of patient reported quality of life outcomes during VMAT, with and without CBCT acquisition, will be hypothesis generating.

Official Title
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Feasibility of Volumetric Modulated Arc Therapy and Cone-Beam Computed Tomography for Head and Neck Carinomas: Analysis of Clinical Throughput and Patient Reported Outcomes.

Conditions
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Head and Neck Carcinoma

Intervention / Treatment
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* Radiation: VMAT with CBCT
* Radiation: VMAT with kV-ray


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VMAT with CBCT<br>Volumetric modulated arc therapy (VMAT) with cone-beam computed tomography position (CBCT) verification | Radiation: VMAT with CBCT<br>* volumetric modulated arc therapy (VMAT) with cone-beam computed tomography (CBCT) position verification<br>|
| Active Comparator: VMAT with kV-ray<br>Volumetric modulation arc therapy (VMAT) with kV-ray position verification | Radiation: VMAT with kV-ray<br>* Volumetric modulated arc therapy (VMAT) with kV-ray position verification<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical efficiency for volumetric modulated arc therapy (VMAT) delivery | 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 | After patient treated | 
| Position verification | Summary description of position verification and online corrections for volumetric modulated arch therapy (VMAT) delivery with and without cone-beam computed tomography (CBCT) | After patient treated | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | 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) | No time frame (ongoing) |