A multi-centred randomised study of parotid sparing intensity modulated radiotherapy (IMRT) to reduce xerostomia and increase quality of life in head and neck cancer

ISRCTN	ISRCTN48243537
DOI	https://doi.org/10.1186/ISRCTN48243537
ClinicalTrials.gov number	NCT00081029
Secondary identifying numbers	Parotid Sparing IMRT

Submission date: 15/10/2002
Registration date: 15/10/2002
Last edited: 29/10/2021

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://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-at-a-new-method-of-radiotherapy-versus-standard-radiotherapy-for-head-and-neck-cancers

Study website

Contact information

Dr Chris Nutting
Scientific

Head and Neck Unit
Royal Marsden NHS Foundation Trust
London
SW3 6JJ
United Kingdom

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

Study information

Study design	Multi-centred randomised study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A multi-centred randomised study of parotid sparing intensity modulated radiotherapy (IMRT) to reduce xerostomia and increase quality of life in head and neck cancer
Study acronym	PARSPORT
Study objectives	Added 30 July 2008: To determine in a randomised controlled trial the potential of intensity-modulated radiotherapy (IMRT) to reduce xerostomia and increase quality of life in head and neck cancer patients.
Ethics approval(s)	Added 30 July 2008: South West MREC (03/6/79) - approved 11/11/2003.
Health condition(s) or problem(s) studied	Head and Neck cancer
Intervention	Patients are randomised to receive either conventional radiotherapy or parotid-sparing IMRT
Intervention type	Other
Primary outcome measure	Added 30 July 2008: The primary endpoint is the proportion of patients suffering xerostomia of grade 2 or more, assessed by the subjective measure on the LENT/SOMA late toxicity scale, one year after treatment.
Secondary outcome measures	Added 30 July 2008: Secondary endpoints include: 1. Degree of xerostomia by quantitative measurements of stimulated and unstimulated salivary flow 2. Xerostomia related quality of life as measured by modified Xerostomia Questionnaire 3. Quality of life measured by the EORTC QLQ C30 v.3.0 and QLQ-H&N35 questionnaires 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 side effects and LENT SOMA and RTOG late radiotherapy scoring systems)
Overall study start date	01/01/2003
Completion date	31/01/2008

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	Added 30 July 2008: 84 (increased to 100 in March 2007). Recruitment completed January 2008, participants in follow up.
Total final enrolment	94
Key inclusion criteria	1. Histologically confirmed squamous cell or undifferentiated carcinoma of the head and neck 2. Tumour arising from the oro-pharynx requiring radical radiation of the primary tumour by parallel opposed lateral fields and bilateral cervical lymph node irradiation. High risk of radiation induced xerostomia with conventional radiotherapy due to irradiation of the majority of both parotid glands. Radiotherapy either as the primary treatment or post-operative (adjuvant irradiation). Neoadjuvant chemotherapy is permitted. 3. All patients must be suitable to attend regular follow-up and undergo QoL and salivary measurements. Stage T1-4, N1-3, M0 disease. Zubrod performance status 0-1.
Key exclusion criteria	Added 30 July 2008: 1. Previous radiotherapy to the head and neck region 2. Previous malignancy except non-melanoma skin cancer 3. Pre-existing salivary gland pathology interfering with saliva production 4. Previous or concurrent illness which in the investigators opinion would interfere with either completion of therapy or follow-up 5. Patients with bilateral N3 nodal disease or huge primary tumour (exceeding 10cm in diameter) 6. Prophylactic use of amifostine or pilocarpine is not allowed 7. Concomitant chemotherapy is not permitted 8. Brachytherapy is not allowed as part of the treatment 9. Presence of contralateral lymphadenopathy adjacent to or involving contralateral parotid gland making parotid sparing impossible 10. Tumour of base of tongue where sparing of contralateral parapharingeal space is contraindicated
Date of first enrolment	01/01/2003
Date of final enrolment	31/01/2008

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Head and Neck Unit

London
SW3 6JJ
United Kingdom

Sponsor information

The Institute of Cancer Research (UK)
Government

123 Old Brompton Road
London
SW7 3RP
United Kingdom

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

Funders

Funder type

Research organisation

Cancer Research UK (CRUK) (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?
Protocol article	protocol	01/10/2007		Yes	No
Other publications	pre-trial quality assurance processes	01/07/2009		Yes	No
Other publications	dosimetry audit	01/10/2009		Yes	No
Results article	parotid-sapring intensity results	01/02/2011		Yes	No
Plain English results		08/11/2011	29/10/2021	No	Yes

Editorial Notes

29/10/2021: The following changes have been made:
1. The Cancer Research UK lay results summary has been added.
2. The total final enrolment number has been added.