Condition category
Cancer
Date applied
15/10/2002
Date assigned
15/10/2002
Last edited
30/05/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.icr.ac.uk

Funders

Funder type

Research organisation

Funder name

Cancer Research UK (CRUK) (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

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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Additional files

Editorial Notes