Condition category
Cancer
Date applied
27/02/2017
Date assigned
06/03/2017
Last edited
06/03/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Safora Johansen

ORCID ID

Contact details

Montebello
Oslo
0310
Norway

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 measures

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

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

https://oslo-universitetssykehus.no

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes