Feasibility of VMAT and CBCT for Head and Neck Carcinomas

Sponsor

British Columbia Cancer Agency (Other)

Overall Status

Completed

CT.gov ID

NCT01384890

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

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.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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.

Study Start Date :

Jul 1, 2011

Actual Primary Completion Date :

May 1, 2012

Actual Study Completion Date :

May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

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

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Months and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jonn Wu, Dr. Jonn Wu, British Columbia Cancer Agency

ClinicalTrials.gov Identifier:

NCT01384890

Other Study ID Numbers:

VMAT, CBCT for H&N ca

First Posted:

Jun 29, 2011

Last Update Posted:

Feb 6, 2013

Last Verified:

Feb 1, 2013

Additional relevant MeSH terms:

Carcinoma

Study Results

No Results Posted as of Feb 6, 2013