Hyperfractionated Radiotherapy With Concomitant Fluorouracil and Hydroxurea for Intermediate Stage Cancer of the Head and Neck
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 4
- 主要终点
- Locoregional control rate
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.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients with head and neck cancer.
详细描述
OBJECTIVES:
- Determine the locoregional control rates, time to failure, need for salvage surgery and overall survival of patients with intermediate stage cancer of the oral cavity, pharynx, larynx, paranasal sinuses, and cervical esophagus.
- Measure the impact of concomitant Hyper-FHX radiotherapy on organ preservation, organ function and quality of life parameters.
- Identify possible prognostic factors for toxic effects and response by performing pharmacologic monitoring.
OUTLINE: Patients receive concomitant chemoradiotherapy with curative intent. Patients who have microscopic or macroscopic residual disease 6 weeks after completion of chemoradiotherapy will receive a surgical salvage procedure.
The first cycle of chemotherapy will begin with PO doses of hydroxyurea every 12 hours on days 0-5. Fluorouracil is given IV on days 0-4. Radiation therapy BID is given on days 1-6. Cycles repeat every 14 days for a total of 5 cycles.
The disease will be reevaluated 4-6 weeks after completion of all treatment, every 3 months for 1 year, then yearly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm A (Hyper-FHX)
Concomitant chemoradiotherapy consisting of hydroxyurea (PO, BID, x 6days), continuous infusion 5-fluorouracil (IV, x 5days), hyperfractionated radiotherapy (150 cGy twice daily for 5 days every 14 days, 5 cycles)
干预措施: fluorouracil (Drug)
Arm A (Hyper-FHX)
Concomitant chemoradiotherapy consisting of hydroxyurea (PO, BID, x 6days), continuous infusion 5-fluorouracil (IV, x 5days), hyperfractionated radiotherapy (150 cGy twice daily for 5 days every 14 days, 5 cycles)
干预措施: hydroxyurea (Drug)
Arm A (Hyper-FHX)
Concomitant chemoradiotherapy consisting of hydroxyurea (PO, BID, x 6days), continuous infusion 5-fluorouracil (IV, x 5days), hyperfractionated radiotherapy (150 cGy twice daily for 5 days every 14 days, 5 cycles)
干预措施: surgical procedure (Procedure)
Arm A (Hyper-FHX)
Concomitant chemoradiotherapy consisting of hydroxyurea (PO, BID, x 6days), continuous infusion 5-fluorouracil (IV, x 5days), hyperfractionated radiotherapy (150 cGy twice daily for 5 days every 14 days, 5 cycles)
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Locoregional control rate
时间窗: 8 years
次要结局
未报告次要终点