COSTAR - a multicentre randomised study of COchlear Sparing intensity modulated radiotherapy versus conventional Radiotherapy in patients with parotid tumours

ISRCTN	ISRCTN81772291
DOI	https://doi.org/10.1186/ISRCTN81772291
ClinicalTrials.gov number	NCT01216800
Secondary identifying numbers	N0258171463

Submission date: 29/09/2006
Registration date: 29/09/2006
Last edited: 27/10/2021

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

http://www.cancerhelp.org.uk/trials/a-trial-looking-at-standard-radiotherapy-and-intensity-modulated-radiotherapy-for-people-with-parotid-gland-cancer

Study website

Contact information

Dr Christopher Nutting
Scientific

Head of Head and Neck Unit
Royal Marsden NHS Trust
Fulham Road
Chelsea
London
SW3 6JJ
United Kingdom

Phone	+44 (0)20 7352 8171
Email	Chris.Nutting@rmh.nhs.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
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	COSTAR - a multicentre randomised study of COchlear Sparing intensity modulated radiotherapy versus conventional Radiotherapy in patients with parotid tumours
Study acronym	COSTAR
Study objectives	To determine in a randomised controlled trial the potential of intensity-modulated radiotherapy (IMRT) to reduce the incidence of sensori neural hearing loss in patients having radiotherapy to the parotid region.
Ethics approval(s)	Royal Marsden Local Research Ethics Committee (UK), 07/03/2006, ref: 05/Q0801/183
Health condition(s) or problem(s) studied	Cancer: Parotid
Intervention	Randomised study testing interventional (COchlear Sparing intensity modulated radiotherapy) vs standardised intervention, non-blinded (Phase III)
Intervention type	Other
Primary outcome measure	Is the proportion of patients developing sensori-neural hearing loss at bone conduction assessed using audiograms at 4000 Hz, one year after treatment?
Secondary outcome measures	Added 30 July 2008: 1. Auditory assessment at 6 and 12 months following radiotherapy and annually thereafter to 5 years 2. Vestibular assessment at baseline, at 6 and 12 months following radiotherapy and annually thereafter to 5 years 3. Quality of life at 6 and 12 months following radiotherapy and annually thereafter for 5 years 4. Local and regional tumour control (a quantitative description of sites of relapse will be performed) 5. Time to tumour progression and overall survival 6. Acute and late side effects of radiotherapy (NCI CTCAE scale v3.0, for acute and late side effects and LENT SOMA and late radiotherapy scoring systems)
Overall study start date	01/07/2008
Completion date	01/08/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	A total of 84 participants including 20 RMH participants.
Key inclusion criteria	Prior to July 2008: 1. Histologically confirmed malignant tumours involving he parotid glands 2. Metastases from squamous cell carcinoma of the head and neck to the parotid gland 3. Benign tumours requiring post operative radiotherapy Modified 30 July 2008: 1. Histologically confirmed malignant tumours of the parotid glands 2. High risk of radiation induced sensori-neural hearing loss with conventional radiotherapy due to the irradiation of the parotid bed to a dose equivalent of 60 Gy in 2 Gy fractions with photon beams, using the wedge pair technique 3. Radiotherapy as post-operative therapy (adjuvant irradiation) 4. WHO Performance Status 0-1 5. All patients must be suitable to attend regular follow-up and undergo audiograms and toxicity monitoring and be available for long term follow-up
Key exclusion criteria	Prior to July 2008: 1. Previous radiotherapy to the head and neck region 2. Previous malignancy except non-melanoma skin cancer 3. Pre-existing hearing loss or significant auditory pathology 4. Previous or concomitant illness, which in the investigators opinion would interfere with either completion of therapy or follow-up 5. Concomitant chemotherapy is not permitted Modified 30 July 2008: 1. Previous radiotherapy to the head and neck region 2. Parotid tumours requiring primary radiation 3. Metastases from squamous cell carcinoma of the head and neck to the parotid gland 4. Benign tumours requiring post operative radiotherapy 5. Hearing loss >60dB at time of study entry (the test is unreliable below this threshold) 6. Previous or concurrent illness, which in the investigators opinion would interfere with either completion of therapy or follow-up 7. Patients requiring concomitant chemotherapy
Date of first enrolment	29/08/2008
Date of final enrolment	31/01/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Royal Marsden NHS Trust

London
SW3 6JJ
United Kingdom

Sponsor information

Institute of Cancer Research (UK)
Research organisation

123 Old Brompton Road
London
SW7 3RP
United Kingdom

Website	http://www.icr.ac.uk/index.shtml
"ROR"	https://ror.org/043jzw605

Funders

Funder type

Charity

Cancer Research UK
Private sector organisation / Other non-profit organizations

Alternative name(s): CR_UK, Cancer Research UK - London, CRUK
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	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2018	29/01/2019	Yes	No
Plain English results		27/10/2021	27/10/2021	No	Yes

Editorial Notes

27/10/2021: The Cancer Research UK lay results summary has been added.
29/01/2019: Publication reference added