Head and Neck Cancer Clinical Trial
Official title:
A Multicenter Randomized Study of Cochlear Sparing Intensity Modulated Radiotherapy Versus Conventional Radiotherapy in Patients With Parotid Tumors
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized
radiation therapy that delivers a high dose of radiation directly to the tumor may kill more
tumor cells and cause less damage to normal tissue. Giving radiation therapy after surgery
may kill any tumor cells that remain after surgery. It is not yet known whether
intensity-modulated radiation therapy or 3-dimensional conformal radiation therapy is more
effective in decreasing hearing loss in patients undergoing radiation therapy for parotid
gland cancer.
PURPOSE: This randomized phase III trial is studying intensity-modulated radiation therapy
to see how well it works compared with 3-dimensional conformal radiation therapy in
decreasing hearing loss in patients who have undergone surgery for 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.
;
Allocation: Randomized, Primary Purpose: Treatment
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