Plain English Summary
Background and study aims
Head and neck cancer is a relatively uncommon type of cancer. Postoperative radiotherapy involves using doses of radiation to kill any cancer cells remaining after surgery to prevent the cancer from returning. If the radiation dose is inadequate or delivered to an inadequate area, this can lead to the tumour coming back (recurrence or relapse). The aim of this study is to look at the patterns of recurrence in head and neck cancer patients.
Who can participate?
Head and neck cancer patients with relapse who have previously undergone radiotherapy
What does the study involve?
Patient data is analysed to find out whether the relapse is related to the treatment they received. Radiotherapy data is analysed to look at the dose given in the primary tumour and relapse area in order to determine whether the relapse was the result of under-dosing of the primary tumour, and to find out whether treatment needs to be changed in order to avoid relapse in the future. There is no further treatment or follow up of the patients.
What are the possible benefits and risks of participating?
Future head and neck patients may benefit if the reason for relapse is found and treatment is changed in order to avoid it. No risks are involved.
Where is the study run from?
Oslo University Hospital (Norway)
When is the study starting and how long is it expected to run for?
January 2015 to October 2016
Who is funding the study?
Oslo University Hospital (Norway)
Who is the main contact?
Dr Safora Johansen
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2014/890
Study information
Scientific title
Patterns of loco-regional recurrence after conformal and intensity-modulated radiotherapy for head and neck cancer: an observational retrospective study
Acronym
Study hypothesis
The aim of this study is to evaluate the patterns of loco-regional recurrences in head and neck cancer patients.
Ethics approval
Committee for medical and research ethics south and east health region, 24/06/2014, ref: 2014/890
Study design
Observational retrospective study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
No participant information sheet available
Condition
Head and neck cancer
Intervention
Patient data is retrospectively and anonymously analysed 4-5 years after completing treatment to find out whether the relapse is related to the treatment they received. The existing radiation data is analysed to see the dose in the primary tumour and relapse area in order to determine whether the relapse was the result of under-dosing of the primary tumour or not, and to find out whether treatment needs to be changed in order to avoid relapse in the future. There is no intervention or follow up of these patients.
Intervention type
Other
Phase
Drug names
Primary outcome measure
The site of tumor recurrence in comparison to primary tumor site, taken from existing patient data at 4-5 years after completing treatment
Secondary outcome measures
Radiation dose in the primary tumour and relapse area, taken from existing patient data at 4-5 years after completing treatment
Overall trial start date
01/01/2015
Overall trial end date
01/10/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Re-irradiation for first relapse in the head and neck region
2. Radiotherapy for both primary and recurrent disease at Oslo University Hospital
3. Computed tomography (CT), and/or positron emission tomography (PET)/magnetic resonance images (MRI) taken prior to radiotherapy
4. Available radiotherapy dose plans for the primary and recurrent disease which were technically possible to co-register
5. Completed their planned curative primary radiation treatment
6. Aged 18 or over
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
26
Participant exclusion criteria
Does not meet the inclusion criteria
Recruitment start date
01/01/2015
Recruitment end date
01/10/2016
Locations
Countries of recruitment
Norway
Trial participating centre
Oslo University Hospital
Oslo
0310
Norway
Sponsor information
Organisation
Oslo University Hospital
Sponsor details
Montebello
Oslo
0310
Norway
-
post@oslo-universitetssykehus.no
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Oslo University Hospital
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The manuscript is ready to be sent for publication in a radiation therapy journal
IPD sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Jan Evensen (JFE@ous-HF.no)
Intention to publish date
01/03/2017
Participant level data
Available on request
Basic results (scientific)
Publication list