A Phase III Double-Blind, Randomized, Placebo-Controlled Study of Erythropoietin When Used as an Adjuvant to Radiation Therapy in Patients With Head and Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 47
- 试验地点
- 15
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Epoetin alfa may help prevent or treat cancer-related anemia. It is not yet known whether radiation therapy is more effective with or without epoetin alfa in treating head and neck cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without epoetin alfa in treating patients who have head and neck cancer.
详细描述
OBJECTIVES:
- Compare the efficacy of radiotherapy (in terms of local-regional control) with or without epoetin alfa in patients with squamous cell carcinoma of the head and neck.
- Compare the disease-specific and overall survival of patients treated with these regimens.
- Compare the hemoglobin level of these patients during radiotherapy.
- Compare the acute and late toxic effects of these regimens in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center, site of disease (larynx vs hypopharynx vs oropharynx vs oral cavity), T-classification (T1-2 vs T3-4), N-classification and intent of systematic neck node dissection (N0-1 vs N2-3 without node dissection vs N2-3 with node dissection), hemoglobin level and gender (men with 10-12.5 g/dL vs men with 12.5-14 g/dL vs women with 10-12 g/dL vs women with 12-13.5 g/dL), and type of treatment (EORTC standard vs other vs randomized in other trials). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo standard radiotherapy 5 days a week and receive concurrent epoetin alfa subcutaneously (SC) once weekly.
- Arm II: Patients undergo radiotherapy as in arm I and receive concurrent placebo SC once weekly.
Treatment on both arms continues for 6-8 weeks in the absence of disease progression or unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed squamous cell carcinoma of the oral cavity, larynx, oropharynx, or hypopharynx
- •Stage T1-T4, any N
- •No T1, N0 glottic tumor
- •No nodal disease from unknown primary
- •Previously untreated disease
- •No distant metastases
- •Planned radiotherapy
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Hemoglobin greater than 10 g/dL but no greater than 14 g/dL for men
- •Hemoglobin greater than 10 g/dL but no greater than 13.5 g/dL for women
- •Not specified
- •Not specified
- •Cardiovascular:
- •No hypertension (diastolic pressure greater than 100 mmHg) refractory to treatment
- •No symptomatic cardiovascular disease
- •No deep vein thrombosis
- •No other malignancy except cured basal cell skin cancer or carcinoma in situ of the cervix
- •No psychological, familial, sociological, or geographical condition that would preclude study compliance
- •No smoking during study
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •No prior neoadjuvant chemotherapy
- •No concurrent chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •See Disease Characteristics
- •No prior radiotherapy to head and neck area
- •No concurrent nonconventional radiotherapy
- •No prior therapeutic surgery to head and neck area
排除标准
- 未提供