A Multicentre Randomised Study Of Parotid Sparing Intensity Modulated Radiotherapy Versus Conventional Radiotherapy In Patients With Head And Neck Cancer
- Compare the proportion of patients with oropharyngeal or hypopharyngeal cancer with
xerostomia of ≥ grade 2 at one year after treatment with parotid-sparing
intensity-modulated radiotherapy vs conventional radiotherapy.
- Compare the degree of xerostomia by quantitative measurements of stimulated and
unstimulated salivary flow in patients treated with these regimens.
- Compare quality of life in patients treated with these regimens.
- Compare local and regional tumor control, time to tumor progression, and overall
survival of patients treated with these regimens.
- Compare acute and late side effects of these regimens in these patients.
OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified
according to participating center and site of disease (oropharynx vs hypopharynx). Patients
are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo parotid-sparing intensity-modulated radiotherapy once daily, 5
days a week, for 6 weeks.
- Arm II: Patients undergo conventional radiotherapy once daily, 5 days a week, for 6
Salivary flow measurements are performed at baseline, at week 4 during radiotherapy, and
then at 2 weeks and at 3, 6, 12, and 24 months after the completion of radiotherapy.
Quality of life is assessed at baseline, at 2 weeks, and then at 3, 6, 12, 18, and 24 months
after the completion of radiotherapy.
Patients are followed monthly for 1 year, every 2 months for 1 year, and then every 6 months
for 3 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 84 patients (42 per treatment arm) will be accrued for this
Allocation: Randomized, Primary Purpose: Treatment
Proportion of patients suffering xerostomia ≥ grade 2 by LENT/SOMA late toxicity scale at 1 year
Royal Marsden NHS Foundation Trust
United States: Federal Government