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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
DOI 10.1186/ISRCTN48243537
ClinicalTrials.gov identifier NCT00081029
EudraCT number
Public 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
Scientific title
Serial number at source Parotid Sparing IMRT
Study hypothesis 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.
Lay summary http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-at-a-new-method-of-radiotherapy-versus-standard-radiotherapy-for-head-and-neck-cancers
Ethics approval Added 30 July 2008: South West MREC (03/6/79) - approved 11/11/2003.
Study design Multi-centred randomised study
Countries of recruitment United Kingdom
Disease/condition/study domain Head and Neck cancer
Participants - 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.
Participants - 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
Anticipated start date 01/01/2003
Anticipated end date 31/01/2008
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants Added 30 July 2008: 84 (increased to 100 in March 2007). Recruitment completed January 2008, participants in follow up.
Interventions Patients are randomised to receive either conventional radiotherapy or parotid-sparing IMRT
Primary outcome measure(s) 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 measure(s) 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)
Sources of funding Cancer Research UK (CRUK) (UK)
Trial website http://www.icr.ac.uk/research/research_sections/clinical_trials/clinical_trials_list/2380_disease.shtml
Publications 1. 2007 protocol in http://www.ncbi.nlm.nih.gov/pubmed/17706404
2. 2009 pre-trial quality assurance processes in http://www.ncbi.nlm.nih.gov/pubmed/19332518
3. 2009 dosimetry audit in http://www.ncbi.nlm.nih.gov/pubmed/19596158
4. 2011parotid-sapring intensity results in http://www.ncbi.nlm.nih.gov/pubmed/21236730
Contact name Dr  Chris  Nutting
  Address Head and Neck Unit
Royal Marsden NHS Foundation Trust
  City/town London
  Zip/Postcode SW3 6JJ
  Country United Kingdom
  Tel +44(0) 20 7352 8171
  Fax +44(0) 20 7808 2048
  Email Chris.nutting@rmh.nhs.uk
Sponsor The Institute of Cancer Research (UK)
  Address 123 Old Brompton Road
  City/town London
  Zip/Postcode SW7 3RP
  Country United Kingdom
  Sponsor website: http://www.icr.ac.uk
Date applied 15/10/2002
Last edited 30/05/2012
Date ISRCTN assigned 15/10/2002
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