Hypofractionated Radiotherapy and Concurrent Cisplatin for Locally Advanced Head and Neck Cancer: A Feasibility Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 主要终点
- To evaluate the rate of patient who could complete the treatment.
研究概览
简要总结
The aim of this study is to evaluate the feasibility of hypofractionated radiation therapy and concomitant chemotherapy with cisplatin for locally advanced head and neck cancer in a high volume brazilian center.
详细描述
To evaluate if concomitant cisplatin and hypofractionated radiation therapy wold be feasible in a brazilian population.
Patients eligibility criteria:
older than 18 years old Biopsy proven squamous cell carcinoma of oropharynx, larynx and hypopharynx. Stage III an IV, with no distant metastasis. ECOG performance status 0-2. Adequate renal and liver function. Good status for radical treatment
Treatment considered feasible if:
- Patient receive at least 90% of radiation dose (18 of 20 fractions of 275cGy)
- Patients receive at least 3 of 4 weekly cycles of cisplatin (35mg/m2)
- Treatment length up to 35 days.
- Grade 4 toxicity lower than 25%
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
- 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
- •Biopsy proven squamous cell carcinoma of oropharynx, larynx and hypopharynx.
- •Stage III an IV, with no distant metastasis.
- •ECOG performance status 0-
- •Adequate renal and liver function.
- •Good status for radical treatment
排除标准
- •Other oncologic treatment before
- •Distant metastasis
- •History of previous malignancy
研究组 & 干预措施
Hypofractionated chemoradiation
20 fractions of 275cGy and concomitant weekly cisplatin 35mg/m2 x 4 cycles
干预措施: Hypofractionated Radiotherapy (Radiation)
Hypofractionated chemoradiation
20 fractions of 275cGy and concomitant weekly cisplatin 35mg/m2 x 4 cycles
干预措施: Weekly cisplatin (Drug)
结局指标
主要结局
To evaluate the rate of patient who could complete the treatment.
时间窗: up to 5 years after patient accrual
The treatment is considered completed when patients receive at least 90% of radiation dose (49,5Gy) with a cumulative cisplatin dose of 105mg/m2 or more (3 of 4 cycles) and the treatment duration is inferior to 35 consecutive days.
To evaluate the rate of participants with treatment-related adverse events
时间窗: up to 5 years after patient accrual
as assessed by investigators using the CTCAE v4.0 criteria
次要结局
- Quality of life according to the EORTC C30 questionaire and EORTC H&N 35 (evaluated together)(up to 18 months from treatment)
- Response rate(up to 4 months after patient accrual)