Plain English Summary
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
7341
Study information
Scientific title
Variation of radiotherapy target volume definition, dose to organs at risk (OAR) and clinical target volumes using anatomic (CT) versus combined anatomic and molecular imaging (PET-CT): Intensity Modulated Radiotherapy delivered using a Tomotherapy Hi Art machine
Acronym
VortigERn
Study hypothesis
30 patients with head and neck cancer who are being treated with intensity modulated radiotherapy (IMRT) will be recruited in the study. Patients willing to give consent to participate will be asked to have a contrast enhanced positron emission tomography - computed tomography (PET-CT) scan. The CT scan data will then be used to define the CTV1 and CTV2 for IMRT treatment (as per agreed protocol) as standard. A computer based IMRT plan will be generated for optimal treatment of the patient using the CT information only. The patient will be treated on the basis of this.
Ethics approval
MREC approved on the 20/10/2008 (ref: 08/H0907/127)
Study design
Non-randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: National Cancer Research Network; Subtopic: All Cancers/Misc Sites; Disease: Unknown Primary Site
Intervention
Standard pre-radiotherapy planning imaging is with a contrast enhanced CT scan. In the study all patients were required to have a 18 FDG PET-CT scan in the treatment position.
Study entry: registration only
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
To explore if the FDG PET CT based radiotherapy target volumes are different to that of CT scan
Secondary outcome measures
Feasibility of dose escalation in tumour volumes in oropharyngeal SCC.
Overall trial start date
01/05/2009
Overall trial end date
02/03/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Tumours of oropharynx area in the head and neck
2. Have involved or uninvolved neck nodes
3. Being treated with tomotherapy IMRT
4. Either sex
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
Planned Sample Size: 30
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/05/2009
Recruitment end date
02/03/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Northern Centre for Cancer Care
Newcastle upon Tyne
NE7 7DN
United Kingdom
Sponsor information
Organisation
Newcastle Hospitals NHS Foundation Trust (UK)
Sponsor details
Freeman Hospital
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Research organisation
Funder name
Royal College of Radiologists (UK)
Alternative name(s)
RCR
Funding Body Type
private sector organisation
Funding Body Subtype
professional associations and societies
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2012 results in https://www.ncbi.nlm.nih.gov/pubmed/23079100