A Phase 2 randomized study to compare short course palliative Radiotherapy with short course concurrent palliative Chemotherapy plus radiotherapy in advanced and unresectable head and neck cancer .
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1.To assess locoregional disease control at 6 months between patients with short course palliative Radiotherapy PRT versus patients with short course concurrent palliative Chemotherapy plus radiotherapy CTRT in advanced and unresectable head and neck cancer.
研究概览
简要总结
Head and Neck cancer (HNSCC )patients present as advance and incurable stage in nearly 30-35% in India.These patients are neither suitable for surgery nor fit for curative RT or chemo-RT approaches.At the same time these advance HNSCC patients are not well defined in Western literature.These patients are similar to lung,Esophagus,Gall Bladder and need Palliative anti-cancer therapy and/or best supportive care.If adding concurrent IV bolus chemotherapy gives an added advantage over palliative RT with toxicities that are acceptable than it will have paradigm change in therapeutic modality in such a group of patients,which comprises nearly one third of HNSCC patients in a country with limited resources.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •A Biopsy proven Squamous cell carcinoma of the Head and Neck region.
- •B ECOG Performance Status of 1/2/
- •C T4b and /or N3 TUMOUR that had been unanimously defined as inoperable and incurable by multidisciplinary team members.
- •D Sites –oral cavity, oropharynx, hypopharynx.
排除标准
- •A Patients with ECOG PS 4 B Non-squamous histology.
- •C H/o previous malignancy at same or other site.
- •D Patients who has received Radiotherapy or Chemotherapy in the past either from IRCH or from other centre.
结局指标
主要结局
1.To assess locoregional disease control at 6 months between patients with short course palliative Radiotherapy PRT versus patients with short course concurrent palliative Chemotherapy plus radiotherapy CTRT in advanced and unresectable head and neck cancer.
时间窗: 6 months from the date of randomization.
2.Proportion of patients eligible for radical RT versus radical CT and RT in each treatment arm.
时间窗: 6 months from the date of randomization.
次要结局
- 1. To assess for degree of symptom relief & palliation between two groups.(2. To compare progression free survival and overall survival between two groups)