Contact information
Type
Scientific
Primary contact
Dr Chris Nutting
ORCID ID
Contact details
Head and Neck Unit
Royal Marsden NHS Foundation Trust
London
SW3 6JJ
United Kingdom
+44(0) 20 7352 8171
Chris.nutting@rmh.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00081029
Protocol/serial number
Parotid Sparing IMRT
Study information
Scientific title
Acronym
PARSPORT
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.
Ethics approval
Added 30 July 2008: South West MREC (03/6/79) - approved 11/11/2003.
Study design
Multi-centred randomised study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Head and Neck cancer
Intervention
Patients are randomised to receive either conventional radiotherapy or parotid-sparing IMRT
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/01/2003
Overall trial end date
31/01/2008
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Not Specified
Gender
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.
Participant 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
Recruitment start date
01/01/2003
Recruitment end date
31/01/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Head and Neck Unit
London
SW3 6JJ
United Kingdom
Sponsor information
Organisation
The Institute of Cancer Research (UK)
Sponsor details
123 Old Brompton Road
London
SW7 3RP
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Research organisation
Funder name
Cancer Research UK (CRUK) (UK)
Alternative name(s)
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
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
Publication citations
-
Protocol
Guerrero Urbano MT, Clark CH, Kong C, Miles E, Dearnaley DP, Harrington KJ, Nutting CM, PARSPORT Trial Management Group, Target volume definition for head and neck intensity modulated radiotherapy: pre-clinical evaluation of PARSPORT trial guidelines., Clin Oncol (R Coll Radiol), 2007, 19, 8, 604-613, doi: 10.1016/j.clon.2007.07.001.
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Dosimetry audit
Clark CH, Hansen VN, Chantler H, Edwards C, James HV, Webster G, Miles EA, Guerrero Urbano MT, Bhide SA, Bidmead AM, Nutting CM, , Dosimetry audit for a multi-centre IMRT head and neck trial., Radiother Oncol, 2009, 93, 1, 102-108, doi: 10.1016/j.radonc.2009.04.025.
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Clark CH, Miles EA, Urbano MT, Bhide SA, Bidmead AM, Harrington KJ, Nutting CM, , Pre-trial quality assurance processes for an intensity-modulated radiation therapy (IMRT) trial: PARSPORT, a UK multicentre Phase III trial comparing conventional radiotherapy and parotid-sparing IMRT for locally advanced head and neck cancer., Br J Radiol, 2009, 82, 979, 585-594, doi: 10.1259/bjr/31966505.
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Nutting CM, Morden JP, Harrington KJ, Urbano TG, Bhide SA, Clark C, Miles EA, Miah AB, Newbold K, Tanay M, Adab F, Jefferies SJ, Scrase C, Yap BK, A'Hern RP, Sydenham MA, Emson M, Hall E, , Parotid-sparing intensity modulated versus conventional radiotherapy in head and neck cancer (PARSPORT): a phase 3 multicentre randomised controlled trial., Lancet Oncol., 2011, 12, 2, 127-136, doi: 10.1016/S1470-2045(10)70290-4.