NCT00004234已完成3 期
A Comparison of Acute Oral Mucositis Between Morning and Afternoon Radiotherapy in Patients Receiving Radiation Treatment for Cancer of the Head and Neck
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 试验地点
- 14
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy at different times of the day may affect the chance of developing side effects such as mucositis.
PURPOSE: Randomized phase III trial to compare the incidence of mucositis in patients who have cancer of the mouth, pharynx, or larynx, who are receiving radiation therapy in either the morning or afternoon.
详细描述
OBJECTIVES:
- Compare the toxicity of radiotherapy to the oral mucosa delivered in the morning or in the late afternoon in patients with squamous cell carcinoma of the oral cavity, pharynx (oro/hypo/naso), or larynx who will receive radiation treatment to a significant part of the oral and/or oropharyngeal mucosa.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, intended smoking behavior during therapy (smoking vs nonsmoking), and planned total radiotherapy dose.
Patients are randomized to receive radiotherapy once daily, 5 days a week, at one of two of the following times of the day:
- Arm I: Patients receive radiotherapy between 8 and 10 AM (local time).
- Arm II: Patients receive radiotherapy between 4 and 6 PM (local time). Treatment continues for 5-8 weeks, depending on planned total radiotherapy dose, in the absence of unacceptable toxicity or disease progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
入排标准
- 年龄范围
- 16 Years 至 120 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, pharynx (oropharynx, hypopharynx, or nasopharynx), or larynx eligible for radical radiotherapy
- •TX, T1-4, NX, N0-3, M0
- •Directly visible area of mucosa including 2 or more protocol specified anatomical locations in the radical target volume
- •At least 6 cm^2 in area irrespective of shape
- •No M1 disease
- •Intention to deliver radiotherapy to a radical dose without chemotherapy
- •May have had surgical resection of the primary or neck nodes
- •Postoperative macroscopic or microscopic residual disease that is eligible for radical radiotherapy is allowed
- •Patients with completely resected disease who are judged to be at high risk of relapse and who are eligible for radical radiotherapy are allowed
- •PATIENT CHARACTERISTICS:
- •16 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Hemoglobin ≥ 10 g/dL
- •Granulocyte count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Not specified
- •Not specified
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •HIV negative
- •Must have normal sleeping habits (i.e., normal circadian rhythm)
- •Must have had dental assessment and necessary prophylactic dental extractions carried out
- •No connective tissue diseases (e.g., systemic lupus, scleroderma, mixed connective tissue disease, rheumatoid arthritis)
- •No organic brain syndrome related to chronic alcohol excess or other cause of sufficient severity that would preclude cooperation with treatment
- •No active uncontrolled infection
- •No history of psychiatric or neurological disorder that would preclude study compliance
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •See Disease Characteristics
- •At least 6 months since prior chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •See Disease Characteristics
- •No prior radiotherapy to the head and neck region
- •See Disease Characteristics
- •No other concurrent oral hygiene regimen other than that described in the protocol
- •No concurrent radioprotective drugs or therapy
排除标准
- 未提供
研究者
研究点 (14)
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