A Multicenter Randomized Study of Cochlear Sparing Intensity Modulated Radiotherapy Versus Conventional Radiotherapy in Patients With Parotid Tumors
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
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
次要结局
- Time to tumor progression
- 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
- 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