Status:
UNKNOWN
Intensity-Modulated Radiation Therapy or 3-Dimensional Conformal Radiation Therapy in Decreasing Hearing Loss in Patients Who Have Undergone Surgery for Parotid Tumors
Lead Sponsor:
Institute of Cancer Research, United Kingdom
Conditions:
Head and Neck Cancer
Ototoxicity
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Detailed Description
OBJECTIVES: Primary * To determine the potential of cochlear-sparing intensity-modulated radiotherapy (IMRT) versus conventional radiotherapy comprising 3-dimensional conformal radiotherapy in reduc...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed malignant tumors of the parotid glands
- Adjuvant radiotherapy planned post-surgery
- No parotid tumors requiring primary radiotherapy
- No benign tumors requiring postoperative radiotherapy
- No metastases from squamous cell carcinoma of the head and neck to the parotid gland
- At high-risk of radiation-induced sensory-neural hearing loss with conventional radiotherapy due to the irradiation of the parotid bed to a dose equivalent of 60 Gy in 2 Gy/fraction with photon beams, using the wedge-pair technique
- PATIENT CHARACTERISTICS:
- WHO performance status 0-1
- No hearing loss \> 60 dB
- No previous or concurrent illness that, in the investigator's opinion, would interfere with either completion of therapy or follow-up
- Suitable to attend regular follow-up and undergo audiograms and toxicity monitoring and be available for long term follow-up
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior radiotherapy to the head and neck region
- No concurrent chemotherapy
Exclusion
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT01216800
Start Date
August 1 2008
Last Update
October 7 2010
Active Locations (1)
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1
Royal Marsden - London
London, England, United Kingdom, SW3 6JJ