Effect of granulocyte colony stimulating factor (G-CSF) in prevention of radiation induced oral mucositis in patients receiving chemo-radiotherapy for head and neck cancer.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To ascertain the efficacy of granulocyte-colony stimulating factor (G-CSF) by
研究概览
简要总结
It is an interventional study. Patients will have to give detailed clinical history and undergo clinical examination with evaluation of the primary tumour, nodes and metastasis. Radiation dose will be 66-70 Gy as total dose, with 2Gy in each fraction given over 5 consecutive days. Chemotherapy will be given as weekly intravenous cisplatin (40mg/m2) as per standard protocol. Patients who have received radiation dose of 10 Gy, will be administered 2µg/kg/day subcutaneously of granulocyte-colony stimulating factor (G-CSF) in the unirradiated normal skin daily till the end of radiation therapy. Patients will be assessed with daily clinical examination, to grade oral mucositis using RTOG criteria(8), and weekly blood tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients having age more than 18 years, and are histologically proven case of squamous cell carcinoma of head and neck with ECOG performance status of 0-
- •Patients who have received a radiation dose of 10Gy to head and neck area during current chemo-radiotherapy treatment.
排除标准
- •Patients with recurrent or metastatic disease or second primary.
- •Prior irradiation to head and neck area.
- •History of anaphylaxis to G-CSF injection.
结局指标
主要结局
To ascertain the efficacy of granulocyte-colony stimulating factor (G-CSF) by
时间窗: weekly during the course of radiation therapy
studying the incidence of grade III/IV oral mucositis, using RTOG criteria
时间窗: weekly during the course of radiation therapy
次要结局
- To study the time of onset & duration for healing of grade III & IV oral mucositis.(Weekly during the course of radiation therapy)
研究者
DEVAL GUPTA
VMMC AND Safdarjung hospital