A randomized prospective study comparing efficacy and toxicity between concurrent accelerated chemoradiotherapy vs concurrent chemoradiotherapy in locally advanced inoperable head and neck squamous cell cancer
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To assess responses
研究概览
简要总结
Approximately 50000 patients were diagnosed annually with squamous cell head and neck (HNC) in United States. Nearly 60% of this population presents with locally advanced but non-metastatic disease. Loco regional failure constitutes the predominant recurrence pattern due to accelerated repopulation of cancer cells.
In our study in standard arm, patients will receive 66 gy in 33# with weekly cisplatin @ 40 mg/meter2 in 6.5 weeks. 5 days per week schdule.
In our experimental arm we shall be giving 66 gy over 5 weeks 3 days in a 6 days per week schdule with concurrent inj cisplatin 40 mg/m^2 weekly.this study has following aims and objectives:
To study the difference between responses in the two arms, according to RECIST V1.1, in terms of Complete Response (CR), Partial Response (PR), Progressive Disease (PD) and Stable Disease (SD) at the end of the treatment.
To study the difference between acute toxicities in the arms, with the help of RTOG radiation morbidity criteria (CTC V1.1). To assess overall survival in both arm, disease free survival (for complete responders) and progression free survival (for partial responders and stable disease).
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 69.00 Year(s)（—）
- 性别
- All
入选标准
- •Age more than 18 yrs and below 70 years
- •Performance status: Upto ECOG-2
- •Histologically & cytologically proven SC HNC.
- •Stage: III, IV, Non-metastatic
- •Measurable & evaluable disease without any severe systematic comorbidity or uncontrolled severe haematological abnormality.
- •Given informed written consent.
排除标准
- •Age: above 70 years.
- •Performance status: poorer than ECOG>
- •Stage: early stage &metastatic disease
- •Histologically any other than squamous cell carcinoma.
- •Previously treated with any type of radiation or chemotherapy: No other previous or co-existing malignancy.
- •Any severe systemic comorbidity or sever.
结局指标
主要结局
To assess responses
时间窗: 2 months
次要结局
- To assess toxicity and survival(3 Months)