Feasibility of VMAT and CBCT for Head and Neck Carcinomas

NCT01384890 | Completed Phase 1

• 1 other identifier: VMAT, CBCT for H&N ca
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Head and Neck Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Quality of life

  No time frame (ongoing)

Study Arms (2)

VMAT with CBCT

EXPERIMENTAL

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

Radiation: VMAT with CBCT

VMAT with kV-ray

ACTIVE COMPARATOR

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

Radiation: VMAT with kV-ray

Interventions

VMAT with CBCT RADIATION

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

VMAT with CBCT

VMAT with kV-ray RADIATION

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

VMAT with kV-ray

Eligibility Criteria

• Age: 18 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• age greater than 18 years
• undergoing radical radiation therapy for head and neck carcinoma at the BC Cancer Agency

You may not qualify if:

• 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

Sponsors & Collaborators

• British Columbia Cancer Agency: lead

Study Sites (1)

BC Cancer Agency - Vancouver Centre

Vancouver, British Columbia, V5Z4E6, Canada

Location

MeSH Terms

Interventions

Radiotherapy, Intensity-Modulated

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Jonn Wu, MD

  British Columbia Cancer Agency

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Jonn Wu

Study Record Dates

• First Submitted: June 28, 2011
• First Posted: June 29, 2011
• Study Start: July 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: February 6, 2013

Record last verified: 2013-02

Locations

CA (1)