Feasibility of VMAT and CBCT for Head and Neck Carcinomas

Phase 1

Completed

• Conditions: Head and Neck Carcinoma
• Interventions: Radiation: VMAT with CBCT; Radiation: VMAT with kV-ray

• Registration Number: NCT01384890
• Lead Sponsor: British Columbia Cancer Agency

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-28
• Study First Submitted QC: 2011-06-28
• Study First Posted: 2011-06-29
• Study Start: 2011-07
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-05
• Last Update Posted: 2013-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VMAT with CBCT	VMAT with CBCT	Volumetric modulated arc therapy (VMAT) with cone-beam computed tomography position (CBCT) verification
VMAT with kV-ray	VMAT with kV-ray	Volumetric modulation arc therapy (VMAT) with kV-ray position verification

Primary Outcome Measures

Name	Time	Method
Clinical efficiency for volumetric modulated arc therapy (VMAT) delivery	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
Position verification	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 Outcome Measures

Name	Time	Method
Quality of life	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)

Trial Locations

Locations (1)

BC Cancer Agency - Vancouver Centre; 🇨🇦 Vancouver, British Columbia, Canada