Intensity-Modulated Radiation Therapy or 3-Dimensional Conformal Radiation Therapy in Decreasing Hearing Loss in Patients Who Have Undergone Surgery for 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.
Head and Neck Cancer
Procedure: adjuvant therapy
Procedure: assessment of therapy complications
Procedure: quality-of-life assessment
Radiation: 3-dimensional conformal radiation therapy
Radiation: intensity-modulated radiation therapy
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||A Multicenter Randomized Study of Cochlear Sparing Intensity Modulated Radiotherapy Versus Conventional Radiotherapy in Patients With Parotid Tumors|
- 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 [ Designated as safety issue: Yes ]
- Auditory assessment at 6 and 12 months following radiotherapy (RT) and then annually thereafter for up to 5 years [ Designated as safety issue: No ]
- Vestibular assessment at baseline, at 6 and 12 months following RT, and then annually thereafter for up to 5 years [ Designated as safety issue: No ]
- Quality of life at 6 and 12 months following RT and then annually thereafter for 5 years [ Designated as safety issue: No ]
- Local and regional tumor control [ Designated as safety issue: No ]
- Time to tumor progression [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Acute and late side effects of RT as assessed by NCI CTCAE v 3.0 and the LENT SOMA and late RT scoring systems [ Designated as safety issue: Yes ]
|Study Start Date:||August 2008|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01216800
|Royal Marsden - London||Recruiting|
|London, England, United Kingdom, SW3 6JJ|
|Contact: Contact Person 44-20-8722-4104 email@example.com|
|Principal Investigator:||Chris Nutting||Royal Marsden NHS Foundation Trust|