Clinical Trial: Intensity-Modulated Radiation Therapy or 3-Dimensional Conformal Radiation Therapy in Decreasing Hearing Loss in Patients Who Have Undergone Surgery for Parotid Tumors

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Multicenter Randomized Study of Cochlear Sparing Intensity Modulated Radiotherapy Versus Conventional Radiotherapy in Patients With Parotid Tumors

Brief Summary:

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.


Detailed Summary:

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
    Sponsor: Institute of Cancer Research, United Kingdom

    Current Primary Outcome: 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

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Auditory assessment at 6 and 12 months following radiotherapy (RT) and then annually thereafter for up to 5 years
    • Vestibular assessment at baseline, at 6 and 12 months following RT, and then annually thereafter for up to 5 years
    • Quality of life at 6 and 12 months following RT and then annually thereafter for 5 years
    • Local and regional tumor control
    • Time to tumor progression
    • Overall survival
    • Acute and late side effects of RT as assessed by NCI CTCAE v 3.0 and the LENT SOMA and late RT scoring systems


    Original Secondary Outcome: Same as current

    Information By: National Cancer Institute (NCI)

    Dates:
    Date Received: October 6, 2010
    Date Started: August 2008
    Date Completion:
    Last Updated: October 6, 2010
    Last Verified: October 2010