Condition category
Cancer
Date applied
29/04/2010
Date assigned
29/04/2010
Last edited
07/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Sanjoy Chatterjee

ORCID ID

Contact details

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

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

http://www.newcastle-hospitals.org.uk/

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

Publication citations

Additional files

Editorial Notes