Feasibility of VMAT and CBCT for Head and Neck Carcinomas

Head and Neck Carcinoma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01384890
• Other study ID #: VMAT, CBCT for H&N ca
• Status: Completed
• Phase: Phase 1
• First received: June 28, 2011
• Last updated: February 5, 2013
• Start date: July 2011
• Est. completion date: May 2012

Study information

• Verified date: February 2013
• Source: British Columbia Cancer Agency
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Months and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Carcinoma

Intervention

Radiation:
• VMAT with CBCT
volumetric modulated arc therapy (VMAT) with cone-beam computed tomography (CBCT) position verification
• VMAT with kV-ray
Volumetric modulated arc therapy (VMAT) with kV-ray position verification

Locations

Country	Name	City	State
Canada	BC Cancer Agency - Vancouver Centre	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
British Columbia Cancer Agency

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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)	No