Randomized Phase 2 Trial of Tirapazamine and the Role of Tumor Hypoxia in Advanced Squamous Head and Neck Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Complete response rate (CRR)
研究概览
简要总结
PURPOSE: Randomized phase 2 trial to compare the effectiveness of chemo-radiation therapy (RT + cisplatin + 5-FU) with or without tirapazamine for the treatment of patients with stage III or IV squamous cell carcinomas of the head and neck cancer (SCCHN).
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells.
Tirapazamine may increase the effectiveness of chemotherapy and radiation therapy by making tumor cells more sensitive to therapy.
详细描述
Subjects were stratified according to pO2 values (high vs low), and randomized to 1 of 2 treatment arms, differing by the addition of tirapazamine to the therapeutic regimen. Treatment consists of two 21-day cycles of induction chemotherapy, followed by radiotherapy (RT).
Induction chemotherapy was cisplatin 100 mg/m2 per day administered over 4 hours on Study Days 1 and 22 (ie, 1st day of both induction cycles) with continuous infusion (CI) 5-FU at a dose of 1000 mg/m2 per day for 120 hours per cycle starting on Study Days 1 and 22 (ie, days 1 to 5 of both induction cycles).
Patients who achieve at least partial response proceeded to chemoradiotherapy (CRT) consisting of localized RT + cisplatin IV + 5-FU +/- tirapazamine. Location of RT was based on whether the site had a CR or PR. Radiotherapy began on day 43 (week 1), and continued for 5.5 weeks. Subjects with no response or progressive disease proceeded to salvage surgery.
A total of 63 patients were accrued for this study over approximately 5 years. 1 subject withdrew consent prior to treatment for personal reasons.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 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
Tirapazamine + cisplatin + 5-FU
2 cycles of induction chemotherapy (tirapazamine, cisplatin, and 5-fluorouracil [5-FU]) followed by simultaneous chemoradiotherapy (tirapazamine, cisplatin, and 5-FU)
干预措施: Tirapazamine (Drug)
Tirapazamine + cisplatin + 5-FU
2 cycles of induction chemotherapy (tirapazamine, cisplatin, and 5-fluorouracil [5-FU]) followed by simultaneous chemoradiotherapy (tirapazamine, cisplatin, and 5-FU)
干预措施: Cisplatin (Drug)
Tirapazamine + cisplatin + 5-FU
2 cycles of induction chemotherapy (tirapazamine, cisplatin, and 5-fluorouracil [5-FU]) followed by simultaneous chemoradiotherapy (tirapazamine, cisplatin, and 5-FU)
干预措施: 5-fluorouracil (Drug)
Tirapazamine + cisplatin + 5-FU
2 cycles of induction chemotherapy (tirapazamine, cisplatin, and 5-fluorouracil [5-FU]) followed by simultaneous chemoradiotherapy (tirapazamine, cisplatin, and 5-FU)
干预措施: Radiotherapy (RT) (Radiation)
Cisplatin + 5-FU
2 cycles of induction chemotherapy (cisplatin + 5-fluorouracil [5-FU]) followed by simultaneous chemoradiotherapy (cisplatin + 5-FU)
干预措施: Cisplatin (Drug)
Cisplatin + 5-FU
2 cycles of induction chemotherapy (cisplatin + 5-fluorouracil [5-FU]) followed by simultaneous chemoradiotherapy (cisplatin + 5-FU)
干预措施: 5-fluorouracil (Drug)
Cisplatin + 5-FU
2 cycles of induction chemotherapy (cisplatin + 5-fluorouracil [5-FU]) followed by simultaneous chemoradiotherapy (cisplatin + 5-FU)
干预措施: Radiotherapy (RT) (Radiation)
结局指标
主要结局
Complete response rate (CRR)
时间窗: 12 weeks
Compare the CRR following CRT with or without tirapazamine in patients with squamous cell carcinoma of the head and neck.
次要结局
- Cause-specific survival (CSS)(5 years)
- Overall survival (OS)(5 years)
- Rate of freedom from recurrence (FFR)(5 years)