A Feasibility Study Of Primary Chemotherapy Followed By Concomitant Chemoradiation With And Without Amifostine In Patients With Locally Advanced Undifferentiated Nasopharyngeal Cancer (UNPC)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 25
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. Giving chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy and radiation therapy.
PURPOSE: Randomized phase II trial to compare the effectiveness of paclitaxel and carboplatin followed by cisplatin plus radiation therapy with or without amifostine in treating patients who have locally advanced cancer of the nasopharynx.
详细描述
OBJECTIVES:
- Compare the overall incidence of grade 3 or 4 mucositis in patients with locally advanced undifferentiated nasopharyngeal cancer treated with paclitaxel and carboplatin followed by cisplatin and radiotherapy with or without amifostine.
- Compare the feasibility and activity of these regimens in these patients.
- Determine the toxicity of paclitaxel and carboplatin in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to WHO performance status (0 vs 1 vs 2), response to induction chemotherapy (complete vs partial vs stable disease vs not evaluable), and participating center.
Patients receive induction chemotherapy comprising paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Patients with a complete or partial response after 2 courses of induction chemotherapy receive 2 additional courses before randomization. Patients with stable disease after 2 courses of induction chemotherapy or who cannot be evaluated after 1 course proceed directly to randomization. Patients are randomized to 1 of 2 treatment arms.
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
- 15 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed undifferentiated nasopharyngeal cancer (UNPC)
- •Locoregionally advanced disease
- •T2b, N1 (greater than 3 cm) or N2
- •T3, N1 (greater than 3 cm) or N2
- •T4, N1 (greater than 3 cm) or N2
- •Any T, N3
- •No squamous cell histology
- •At least 1 unidimensionally measurable target lesion
- •At least 20 mm by conventional techniques OR
- •At least 10 mm by spiral CT scan
- •No evidence of distant metastases
- •No signs or symptoms of CNS metastases
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute neutrophil count at least 2,000/mm^3
- •Platelet count at least 150,000/mm^3
- •Hemoglobin at least 12 g/dL
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •AST/ALT no greater than 2.5 times ULN
- •Creatinine clearance at least 70 mL/min
- •Calcium normal
- •Cardiovascular:
- •No hypotension or hypertension requiring therapy
- •No prior myocardial infraction
- •No pre-existing uncontrolled cardiac disease
- •No signs of cardiac failure
- •No rhythm disturbances requiring medication
- •No sensory neuropathy grade 2 or greater unless due to cranial nerve
- •No uncontrolled infections
- •No sensitivity to aminothiol compounds
- •No other malignancy within the past 5 years except adequately controlled carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
- •No psychological, familial, sociological, or geographical condition that would preclude study
- •Fertile patients must use effective contraception during and for 3 months after study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No concurrent immunotherapy
- •Chemotherapy:
- •No prior chemotherapy for UNPC
- •Endocrine therapy:
- •No concurrent hormonal therapy except corticosteroids for antiemetic prophylaxis
- •Radiotherapy:
- •No prior radiotherapy for UNPC
- •No prior surgery for UNPC except cervical lymphadenectomy
- •At least 1 month since prior investigational agent
- •No other concurrent anticancer drugs
排除标准
- 未提供