Patterns of loco-regional recurrence after conformal and intensity-modulated radiotherapy for head and neck cancer

ISRCTN	ISRCTN17397551
DOI	https://doi.org/10.1186/ISRCTN17397551
Secondary identifying numbers	2014/890

Submission date: 27/02/2017
Registration date: 06/03/2017
Last edited: 06/03/2017

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Safora Johansen
Scientific

Montebello
Oslo
0310
Norway

Study information

Study design	Observational retrospective study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	No participant information sheet available
Scientific title	Patterns of loco-regional recurrence after conformal and intensity-modulated radiotherapy for head and neck cancer: an observational retrospective study
Study objectives	The aim of this study is to evaluate the patterns of loco-regional recurrences in head and neck cancer patients.
Ethics approval(s)	Committee for medical and research ethics south and east health region, 24/06/2014, ref: 2014/890
Health condition(s) or problem(s) studied	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
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 study start date	01/01/2015
Completion date	01/10/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	26
Key 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
Key exclusion criteria	Does not meet the inclusion criteria
Date of first enrolment	01/01/2015
Date of final enrolment	01/10/2016

Locations

Countries of recruitment

Norway

Study participating centre

Oslo University Hospital

Oslo
0310
Norway

Sponsor information

Oslo University Hospital
Hospital/treatment centre

Montebello
Oslo
0310
Norway

Email	post@oslo-universitetssykehus.no
Website	https://oslo-universitetssykehus.no
"ROR"	https://ror.org/00j9c2840

Funders

Funder type

Hospital/treatment centre

Oslo University Hospital

No information available

Results and Publications

Intention to publish date	01/03/2017
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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)