Head and Neck cancer Cancer Malignant neoplasm of other and ill-defined sites
Conditions
Interventions
Patients are randomised to receive either conventional radiotherapy or parotid-sparing IMRT
Sponsors
The Institute of Cancer Research (UK)
Eligibility
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
England, United Kingdom
Outcome results
None listed