Condition category
Cancer
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
14/04/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Christopher Nutting

ORCID ID

Contact details

Head of Head and Neck Unit
Royal Marsden NHS Trust
Fulham Road
Chelsea
London
SW3 6JJ
United Kingdom
+44 (0)20 7352 8171
Chris.Nutting@rmh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT01216800

Protocol/serial number

N0258171463

Study information

Scientific title

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

Acronym

COSTAR

Study hypothesis

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

Royal Marsden Local Research Ethics Committee (UK), 07/03/2006, ref: 05/Q0801/183

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cancer: Parotid

Intervention

Randomised study testing interventional (COchlear Sparing intensity modulated radiotherapy) vs standardised intervention, non-blinded (Phase III)

Intervention type

Other

Phase

Phase III

Drug names

Primary outcome measures

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 trial start date

01/07/2008

Overall trial end date

01/08/2016

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

A total of 84 participants including 20 RMH participants.

Participant 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

Recruitment start date

29/08/2008

Recruitment end date

31/01/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Marsden NHS Trust
London
SW3 6JJ
United Kingdom

Sponsor information

Organisation

Institute of Cancer Research (UK)

Sponsor details

123 Old Brompton Road
London
SW7 3RP
United Kingdom

Sponsor type

Research organisation

Website

http://www.icr.ac.uk/index.shtml

Funders

Funder type

Charity

Funder name

Cancer Research UK

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes