NCT00020631已完成不适用
A Pilot Study Of Pirfenidone For The Treatment Of Radiation-Induced Fibrosis
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Pirfenidone may prevent or lessen fibrosis caused by radiation therapy.
PURPOSE: Pilot trial to study the effectiveness of pirfenidone in preventing or lessening fibrosis in patients who have undergone radiation therapy for cancer.
详细描述
OBJECTIVES:
- Determine the safety and therapeutic efficacy of pirfenidone in cancer patients with radiation-induced fibrosis.
OUTLINE: Patients receive oral pirfenidone 3 times daily. Treatment continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
Principal functional abilities are assessed at baseline, every 3 months, and at termination of therapy.
PROJECTED ACCRUAL: A total of 10-25 patients will be accrued for this study within 1 year.
研究设计
- 研究类型
- Interventional
- 主要目的
- Supportive Care
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:
- •Regional post-radiation fibrosis of a specific body area (e.g., neck, back, or extremities)
- •At least moderate impairment in at least 1 of the following principal functional abilities:
- •Range of motion
- •Swallowing
- •Prior radiation for cancer received more than 6 months ago
- •No evidence of recurrent or metastatic cancer
- •No history of collagen vascular disease
- •No positive antinuclear antibody
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Hepatitis B and C negative
- •Not specified
- •HIV negative
- •No evidence of second primary cancer
- •No life-threatening situation requiring rehabilitation intervention
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No concurrent anticancer immunotherapy
- •Chemotherapy:
- •No concurrent anticancer chemotherapy
- •Endocrine therapy:
- •No concurrent anticancer hormonal therapy
- •Radiotherapy:
- •See Disease Characteristics
- •No concurrent anticancer radiotherapy
- •Not specified
- •No other concurrent anticancer investigational agents
- •Stable doses of medicine (e.g., non-steroidal anti-inflammatory drugs) currently being taken are allowed
排除标准
- 未提供
研究者
研究点 (2)
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