A Pilot study on moderate accelerated radiotherapy in locoregionally advanced squamous cell carcinomas of Hypopharynx and Larynx - a prospective feasibility study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The primary end point would be treatment completion rates (proportion of patients completing the planned treatment) for feasibility
研究概览
简要总结
Trial is yet to start recruitment.
Aim of the study is -
To evaluate the tolerability and feasibility of moderate accelerated radiotherapy (6 fractions per week) in locoregionally advanced squamous cell carcinomas of Hypopharynx and Larynx undergoing radical radiotherapy with or without chemotherapy at our institute.
Treatment plan-
Moderate Accelerated Radiotherapy (RT): will be given to a total dose of 66 Gy, 2Gy/day for 33 fractions, 6 days a week, total 5.5 weeks instead of the conventional 5 days a week, total 6.5 weeks. RT will be given to primary tumour and nodal areas as per the clinical and radiological findings.Chemotherapy: weekly Inj.Cisplatin 30 mg/m2 or weekly Inj Docetaxel 15 mg/m2
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.All patients of newly diagnosed locally advanced stage III-IV squamous cell carcinomas of hypopharynx and larynx subsite, not for surgery, eligible to receive Radical radiotherapy with or without chemotherapy.
- •2.Age between 18 to 75 years.
排除标准
- •1.Patients with distant metastatic disease 2.Those who have undergone surgery and recurrent disease status.
- •Patient is mentally incapacitated or has a significant emotional aspect.
结局指标
主要结局
The primary end point would be treatment completion rates (proportion of patients completing the planned treatment) for feasibility
时间窗: The treatment completion rates (proportion of patients completing the planned treatment) will be assessed at the end of radiotherapy treatment | 2.The proportion of patients who develop Grade 3 and 4 toxicity as per RTOG/CTCAE criteria will be assessed every week during radiotherapy, 6 weeks post therapy and then monthly once upto 1 year
2.The proportion of patients who develop Grade 3 and 4 toxicity as per RTOG/CTCAE criteria.
时间窗: The treatment completion rates (proportion of patients completing the planned treatment) will be assessed at the end of radiotherapy treatment | 2.The proportion of patients who develop Grade 3 and 4 toxicity as per RTOG/CTCAE criteria will be assessed every week during radiotherapy, 6 weeks post therapy and then monthly once upto 1 year
次要结局
- The proportion of patients developing complete response, partial response and progressive disease during follow up.