Palliative hypofractionated radiotherapy with or without chemotherapy in locally advanced head and neck squamous cell carcinoma -a randomised controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- 1. To compare the progression-free survival (PFS) in both arms.
研究概览
简要总结
Palliative radiotherapy has now become a standard palliative modality in locally advanced head and neck cancers. In locally advanced cases, if we have to extend the survival and achieve lasting palliation, enhancing overall response is crucial. We believe that 5250 cGy in 15 fractions may not deliver a sufficiently tumoricidal dose, even with concurrent chemotherapy since most of our patients have very large tumour and nodal volumes at presentation. Additionally, irradiating only the tumour with the involved nodal region can lead to recurrences in the adjacent nodal areas. To address this, two approaches can be considered:
- We can consider reducing the tumour volume by giving chemotherapy for downstaging the tumour before radiation. 2. irradiating not only the involved nodal region but also the adjacent at-risk levels to an elective dose.
Administering chemotherapy before radiation has the potential to reduce the tumor volume which in turn, allows radiation to target a smaller tumor volume, potentially boosting its effectiveness. Therefore chemotherapy followed by hypofractionated radiotherapy in locally advanced head and neck cancers is expected to improve the overall response and progression-free survival resulting in prolonged palliation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age: above 18 years less than 80 yrs.
- •Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, larynx and hypopharynx.
- •Stage: cT4a, T4b, N1-3, M0, and ECOG Performance status: 2-3, planned for palliative radiation.
- •Patient with normal renal, haematological and hepatic parameters.
排除标准
- •Any patient with Stage: cT1-3, N1,2a,b,c, M0, ECOG PS: 0,1, squamous cell carcinoma of the head and neck planned for curative intent treatment- definitive or adjuvant radiation
- •Cancers arising from the salivary gland, nasal cavity, paranasal sinuses and nasopharynx 3.Abnormal renal function (creatinine clearance less than 45 ml/min), haematological parameters (grade 3-4 neutropenia and thrombocytopenia ) and liver function (serum Alkaline Phosphatase more than 6 times the normal upper limit, serum AST +/or ALT more than 3.5 times the normal upper limit) 4.Cardiovascular abnormalities which include prior history of myocardial infarction, angina, dysrhythmias, Coronary Artery Disease(CAD), cardiac failure.
- •Previous history of hypersensitivity to Docetaxel or platinum-containing compounds
- •Recurrent tumors
- •Uncontrolled co-morbidities
- •Non squamous pathology.
- •Prior history of radiation 10.
结局指标
主要结局
1. To compare the progression-free survival (PFS) in both arms.
时间窗: Expected time to follow up - 14 months. Events for PFS will include disease progression, relapse (locoregional or distant), the development of a second primary, or death from any cause. PFS will be defined as the time from random assignment to attainment of an event for PFS
次要结局
- 1. To compare the overall response of the tumour in both arms assessed by contrast-enhanced CT of the head and neck using RECIST 1.1 criteria(3 months post-treatment)
- 2. To compare the locoregional control (LRC) in both arms assessed by contrast-enhanced CT of the head and neck, using RECIST 1.1 criteria(6 months and 1 year post-treatment)
- To compare the overall survival (OS) in both arms.(Events for OS will include death from any cause. OS will be measured from the time of random assignment to death from any cause.)
- 4. To compare the quality of life in both arms using EORTC QOL 30 and EORTC QOL 35 questionnaire version 3.0(6 months post radiation.)
- 5. To compare the proportion of patients developing acute and late side effects of radiation using acute and late RTOG toxicity scoring criteria and CTCAE version 5.0 toxicity criteria.(Weekly during the course of radiation and 3 months post treatment)
- 6. To assess the proportion of patients developing chemotherapy toxicity using CTCAE version 5.0 toxicity criteria.(Weekly during the course of chemotherapy.)
研究者
Mruthulagi S P
Jawaharlal Institute of Post Graduate Medical Education and Research, JIPMER, Puducherry