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

ISRCTN	ISRCTN33175361
DOI	https://doi.org/10.1186/ISRCTN33175361
Protocol serial number	7341
Sponsor	Newcastle Hospitals NHS Foundation Trust (UK)
Funder	Royal College of Radiologists (UK)

Submission date: 29/04/2010
Registration date: 29/04/2010
Last edited: 12/12/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://cancerhelp.cancerresearchuk.org/trials/a-study-see-pet-scans-help-improve-radiotherapy-treatment-planning-oropharyngeal-cancer-vortigern

Contact information

Dr Sanjoy Chatterjee
Scientific

Northern Centre for Cancer Care
Freeman Hospital
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom

Study information

Primary study design	Interventional
Study design	Non-randomised interventional treatment trial
Secondary study design	Non randomised controlled trial
Study type	Participant information sheet
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
Study acronym	VortigERn
Study objectives	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(s)	MREC approved on the 20/10/2008 (ref: 08/H0907/127)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	To explore if the FDG PET CT based radiotherapy target volumes are different to that of CT scan
Key secondary outcome measure(s)	Feasibility of dose escalation in tumour volumes in oropharyngeal SCC.
Completion date	02/03/2010

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	30
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/05/2009
Date of final enrolment	02/03/2010

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Northern Centre for Cancer Care

Newcastle upon Tyne
NE7 7DN
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

12/12/2017: Publication reference added.