| Source of record | UK Trials |
| ISRCTN | ISRCTN48243537 |
| Date ISRCTN assigned | 15/10/2002 |
| Local reference number(s) | Parotid Sparing IMRT |
| 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 |
|
| Acronym | N/A |
| Disease/condition/study domain | Head and Neck |
| Study hypothesis | Not provided at time of registration. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration. |
| Countries of trial | United Kingdom |
| 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 | Not provided at time of registration. |
| Patient information material |
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| Anticipated start date | 01/10/2001 |
| Anticipated end date | 01/10/2006 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration. |
| Interventions | Patients are randomised to receive either conventional radiotherapy or parotid-sparing IMRT |
| Primary outcome measure(s) | Not provided at time of registration. |
| Secondary outcome measure(s) | Not provided at time of registration. |
| Sources of funding | Institute of Cancer Research |
| Sponsor name | The Institute of Cancer Research (UK) |
| Sponsor details | 123 Old Brompton Road
London
United Kingdom
SW7 3RP |
| Sponsor telephone | +44(0) 20 7352 8133 |
| Sponsor fax | +44(0) 20 7370 5261 |
| Sponsor email | sponsor@unknown.com |
| Sponsor website | http://www.icr.ac.uk |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN48243537 |
| Date last extracted from ISRCTN register | 17/04/2008 |
