Effect of Hypofractionated Palliative Radiotherapy on Quality of Life in Late Stage Oral Cavity Cancer:A Prospective clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- To assess the effect of hypofractionated palliative radiotherapy on quality of life in patients with late stage oral cavity cancer with the EORTC H&N 35 questionnaire with specific attention to pain,swallowing and mouth opening sub scales
研究概览
简要总结
Late stage oral cavity cancers can be extremely debilitating and the need for achieving symptomatic relief and local disease control can’t be overstated. Most of these patients have poor performance status, very advanced loco-regional disease , comorbid illnesses, old age or a combination of these factors which make the attempts at radical treatments questionable. The focus should be to identify an optimal palliative radiotherapy schedule which will minimise patient dropout during treatment by minimising side effects and at the same time result in tumor regression and palliation of symptoms. Our experimental arm shall receive a dose of 5250cGy in 15 fractions with a biologically equivalent dose of 5906 cGy with advantages as stated below
i) Shortened overall treatment time, and therefore better compliance and less dropouts during treatment. ii)Shortened overall treatment time results in completion of treatment before the tumour repopulation sets in and therefore better tumour control
iii) Delivering a biological equivalent dose of around 64 Gy will also ensure adequate tumour regression and improve local control.
We are aiming to assess the quality of life using the EORTC QLQ C30 and H&N 35 questionnaire and the clinical complete response by CT/MRI imaging ( according to RECIST guidelines 1.1), and median survival of the study group.If a 3 week schedule of radiation therapy could be developed which would shorten the treatment time it will enhance the compliance of patients to treatment. A higher dose per fraction can also achieve higher local control thereby leading to prolonged palliation and possibly prolonged survival
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 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
- •i)Biopsy proven Squamous cell carcinoma ii)Surgically unresectable stage IVB oral cavity cancer where oral cavity is defined as consisting of lip, alveolus, floor of mouth, hard palate, retromolar trigone, buccal mucosa and tongue (extension to infratemporal fossa extension,masticator space, pterygoid plates, or skull bases or encases internal carotid artery ) iii)Stage IVA disease- not fit for surgery/ curative treatment iv)Stage IVC disease-for palliation of local symptoms v)No previous history of radiotherapy/chemotherapy/surgery vi)No previous history of cancer.
排除标准
- •i)Patients with another primary at a different site ii)Pregnant women iii)Age <18 and >80 years.
结局指标
主要结局
To assess the effect of hypofractionated palliative radiotherapy on quality of life in patients with late stage oral cavity cancer with the EORTC H&N 35 questionnaire with specific attention to pain,swallowing and mouth opening sub scales
时间窗: 2 months
次要结局
- Median survival(6 months)
- Acute toxicity during radiation therapy – using RTOG/CTCAE grading.(2 months)
- Assessment of general quality of life as per the QLQ C30 and other parameters in the H&N 35(2 months)
- Late toxicity using RTOG/CTCAE grading14(6 months)
- Compliance to the treatment regimen(6 months)
- The response rates as assessed by the RECIST guidelines 1.1-complete, partial, overall response rates(2 months)