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 |
| Secondary identifying numbers | 7341 |
- 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
Contact information
Dr Sanjoy Chatterjee
Scientific
Scientific
Northern Centre for Cancer Care
Freeman Hospital
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Study information
| Study design | Non-randomised interventional treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/05/2009 |
| Completion date | 02/03/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | Planned Sample Size: 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
- England
- United Kingdom
Study participating centre
Northern Centre for Cancer Care
Newcastle upon Tyne
NE7 7DN
United Kingdom
NE7 7DN
United Kingdom
Sponsor information
Newcastle Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Freeman Hospital
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
England
United Kingdom
| Website | http://www.newcastle-hospitals.org.uk/ |
|---|---|
"ROR" |
https://ror.org/05p40t847 |
Funders
Funder type
Research organisation
Royal College of Radiologists (UK)
Private sector organisation / Associations and societies (private and public)
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- The Royal College of Radiologists, RCR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
12/12/2017: Publication reference added.
