Cancer: Parotid Cancer Malignant neoplasm of parotid gland
Conditions
Interventions
Randomised study testing interventional (COchlear Sparing intensity modulated radiotherapy) vs standardised intervention, non-blinded (Phase III)
Added 27/11/2025:
Additional Data Linkage Information
Sponsors
Institute of Cancer Research (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Prior to July 2008: 1. Histologically confirmed malignant tumours involving the parotid glands 2. Metastases from squamous cell carcinoma of the head and neck to the parotid gland 3. Benign tumours requiring post operative radiotherapy Modified 30 July 2008: 1. Histologically confirmed malignant tumours of the parotid glands 2. High risk of radiation induced sensori-neural hearing loss with conventional radiotherapy due to the irradiation of the parotid bed to a dose equivalent of 60 Gy in 2 Gy fractions with photon beams, using the wedge pair technique 3. Radiotherapy as post-operative therapy (adjuvant irradiation) 4. WHO Performance Status 0-1 5. All patients must be suitable to attend regular follow-up and undergo audiograms and toxicity monitoring and be available for long term follow-up
Exclusion criteria
Exclusion criteria: Prior to July 2008: 1. Previous radiotherapy to the head and neck region 2. Previous malignancy except non-melanoma skin cancer 3. Pre-existing hearing loss or significant auditory pathology 4. Previous or concomitant illness, which in the investigators opinion would interfere with either completion of therapy or follow-up 5. Concomitant chemotherapy is not permitted Modified 30 July 2008: 1. Previous radiotherapy to the head and neck region 2. Parotid tumours requiring primary radiation 3. Metastases from squamous cell carcinoma of the head and neck to the parotid gland 4. Benign tumours requiring post operative radiotherapy 5. Hearing loss >60 dB at time of study entry (the test is unreliable below this threshold) 6. Previous or concurrent illness, which in the investigators opinion would interfere with either completion of therapy or follow-up 7. Patients requiring concomitant chemotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Is the proportion of patients developing sensori-neural hearing loss at bone conduction assessed using audiograms at 4000 Hz, 1 year after treatment? | — |
Secondary
| Measure | Time frame |
|---|---|
| Added 30 July 2008: 1. Auditory assessment at 6 and 12 months following radiotherapy and annually thereafter to 5 years 2. Vestibular assessment at baseline, at 6 and 12 months following radiotherapy and annually thereafter to 5 years 3. Quality of life at 6 and 12 months following radiotherapy and annually thereafter for 5 years 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 and late side effects and LENT SOMA and late radiotherapy scoring systems) | — |
Countries
England, United Kingdom
Outcome results
None listed