A Multicenter Randomized Study of Cochlear Sparing Intensity Modulated Radiotherapy Versus Conventional Radiotherapy in Patients With Parotid Tumors
OBJECTIVES:
Primary
- To determine the potential of cochlear-sparing intensity-modulated radiotherapy (IMRT)
versus conventional radiotherapy comprising 3-dimensional conformal radiotherapy in
reducing the incidence of sensory-neural hearing loss in patients with parotid tumors
undergoing radiotherapy to the parotid region.
Secondary
- To describe and compare the impact of both IMRT and conventional radiotherapy on
physical, social and emotional well-being including generic functional and symptom
aspects as well as disease-specific issues relevant to audiometry.
OUTLINE: This is a multicenter study. Patients are stratified according to center and
radiotherapy dose. Patients are randomized to 1 of 2 treatment arms after surgical
resection.
- Arm I (cochlear-sparing intensity-modulated radiotherapy [IMRT]): Patients undergo
cochlear-sparing IMRT using the local planning system once daily, 5 days per week, for
6 weeks (total of 30 fractions) at a total dose of 60 Gy (65 Gy if macroscopic residual
disease). Patients may undergo elective neck irradiation of the uninvolved lymph node
areas once daily, 5 days per week, for 6 weeks.
- Arm II (conventional radiotherapy): Patients undergo conventional radiotherapy
comprising 3-dimensional conformal radiotherapy once daily, 5 days per week, for 6
weeks (total of 30 fractions) at a total dose of 60 Gy (65 Gy if macroscopic residual
disease). Patients may undergo elective neck irradiation of the uninvolved lymph node
areas once daily, 5 days a week, for 5 weeks.
Patients complete quality-of-life questionnaires (EORTC QLQC30 v.3.0, the head and neck
module H&N35, and a modified version of the Glasgow Hearing Aid Benefit profile) at baseline
and at 6,12, 24, 36, 48, and 60 months after completion of study therapy. Patients also
undergo audiological and vestibular assessment at 6 and 12 months following radiotherapy and
then annually thereafter for up to 5 years.
After completion of study treatment, patients are followed up at 3, 6, 12, 18, and 24 months
and then annually thereafter for up to 5 years (annually for recurrence for at least 10
years).
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Proportion of patients developing sensory-neural hearing loss of at least 10 dB at bone conduction as assessed by audiograms at 4000 Hz one year after treatment
Yes
Chris Nutting
Principal Investigator
Royal Marsden NHS Foundation Trust
Unspecified
CDR0000686212
NCT01216800
August 2008
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