NCT00081029Unknown3 期
A Multicentre Randomised Study Of Parotid Sparing Intensity Modulated Radiotherapy Versus Conventional Radiotherapy In Patients With Head And Neck Cancer
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 84
- 试验地点
- 9
- 主要终点
- Proportion of patients suffering xerostomia ≥ grade 2 by LENT/SOMA late toxicity scale at 1 year
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Intensity-modulated radiation therapy delivers thin beams of radiation of different strengths directly to the tumor from many angles. This type of radiation therapy may reduce damage to the parotid (salivary) glands, prevent xerostomia (dry mouth), and improve quality of life. It is not yet known whether intensity-modulated radiation therapy is more effective than conventional radiation therapy in preventing xerostomia and improving quality of life in patients who have throat cancer.
PURPOSE: This randomized phase III trial is studying intensity-modulated radiation therapy to see how well it works compared to conventional radiation therapy in treating patients with oropharyngeal or hypopharyngeal cancer who are at risk of developing xerostomia caused by radiation therapy.
详细描述
OBJECTIVES:
Primary
- Compare the proportion of patients with oropharyngeal or hypopharyngeal cancer with xerostomia of ≥ grade 2 at one year after treatment with parotid-sparing intensity-modulated radiotherapy vs conventional radiotherapy.
Secondary
- Compare the degree of xerostomia by quantitative measurements of stimulated and unstimulated salivary flow in patients treated with these regimens.
- Compare quality of life in patients treated with these regimens.
- Compare local and regional tumor control, time to tumor progression, and overall survival of patients treated with these regimens.
- Compare acute and late side effects of these regimens in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed oropharyngeal or hypopharyngeal cancer
- •Squamous cell or undifferentiated carcinoma
- •Stage T1-4, N0-3, M0 disease
- •Primary tumor requiring radical radiotherapy with parallel opposed lateral fields and bilateral cervical lymph node irradiation
- •Radiotherapy is either the primary therapy or post-operative (adjuvant irradiation) treatment
- •High-risk for radiation-induced xerostomia with conventional radiotherapy due to irradiation of the majority of both parotid glands* NOTE: *Estimated mean dose to both parotid glands is greater than 24 Gy by conventional radiotherapy
- •No bilateral N3 nodal disease
- •No huge primary tumor (exceeding 10 cm in diameter)
- •No contralateral lymphadenopathy adjacent to or involving contralateral parotid gland making parotid sparing impossible
- •No tumor at the base of the tongue where sparing of contralateral parapharyngeal space is contraindicated
- •PATIENT CHARACTERISTICS:
- •Not specified
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •Able to undergo quality of life and salivary flow measurements (dependent on cognitive aptitude and long availability)
- •Able to complete self-assessed quality of life questionnaire
- •No prior or concurrent illness that would preclude study participation
- •No pre-existing salivary gland pathology interfering with saliva production
- •No other prior malignancy except nonmelanoma skin cancer
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Prior neoadjuvant chemotherapy allowed
- •No concurrent chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •See Disease Characteristics
- •No prior radiotherapy to the head and neck region
- •No concurrent brachytherapy
- •See Disease Characteristics
- •No concurrent prophylactic amifostine or pilocarpine
排除标准
- 未提供
结局指标
主要结局
Proportion of patients suffering xerostomia ≥ grade 2 by LENT/SOMA late toxicity scale at 1 year
次要结局
- Overall survival at 1 year
- Time to tumor progression at 1 year
- Acuteside effects of radiotherapy by NCI CTCAE scale v. 3.0 at 1 year
- Late side effects of radiotherapy by NCI CTCAE scale v3.0, LENT SOMA and RTOG at 1 year
- Degree of xerostomia by salivary flow at 1 year
- Xerosomia-related quality of life by Modified Xerostomia questionnaire at 1 year
- Quality of Life by EORTC QLQ C30 v.3.0 and QLQ-H&N35 questionnaires at 1 year
- Local and regional tumor control by a quantitative description of sites of relapse at 1 year
研究者
研究点 (9)
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