Head and Neck Cancer Clinical Trial
Official title:
A Multicentre Randomised Study Of Parotid Sparing Intensity Modulated Radiotherapy Versus Conventional Radiotherapy In Patients With Head And Neck Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells.
Intensity-modulated radiation therapy delivers thin beams of radiation of different
strengths directly to the tumor from many angles. This type of radiation therapy may reduce
damage to the parotid (salivary) glands, prevent xerostomia (dry mouth), and improve quality
of life. It is not yet known whether intensity-modulated radiation therapy is more effective
than conventional radiation therapy in preventing xerostomia and improving quality of life
in patients who have throat cancer.
PURPOSE: This randomized phase III trial is studying intensity-modulated radiation therapy
to see how well it works compared to conventional radiation therapy in treating patients
with oropharyngeal or hypopharyngeal cancer who are at risk of developing xerostomia caused
by radiation therapy.
OBJECTIVES:
Primary
- 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.
Secondary
- 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
weeks.
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
study.
;
Allocation: Randomized, Primary Purpose: Treatment
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