Palliative Radiotherapy in Addition to Self-expanding Metal Stent for Improving Dysphagia and Survival in Advanced Oesophageal Cancer: ROCS (Radiotherapy After Oesophageal Cancer Stenting) Study.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 32
- 主要终点
- patient-reported dysphagia
研究概览
简要总结
The single most distressing symptom for more than 70% of patients with oesophageal cancer is difficulty in swallowing (dysphagia) caused by blockage of the gullet by a tumour. This causes severe restrictions on food intake, physical activity, social functioning and overall quality of life. Amongst the more effective treatments for improving swallowing, is the insertion of a metal stent across the blocked part, which then self-expands to open up the gullet (Self Expanding Metal Stent or SEMS). The addition of radiotherapy may help to improve the problems caused by dysphagia and provide an additional survival benefit.
The purpose of this study is to test the impact of adding radiotherapy to SEMS on:
- the length of time swallow remains improved for
- quality of life
- survival
详细描述
The primary objective of the study is to assess the impact of radiotherapy in addition to self-expanding metal stent (SEMS) placement on time to progression of patient-reported dysphagia in a patient population unable to undergo surgery.
Patients will be eligible to take part in the trial if they have oesophageal cancer, are in need of SEMS because of dysphagia, are aged 16 years or older, have been clinically assessed to be able to receive radiotherapy, have an expected survival of at least 12 weeks and are able to give written informed consent.
496 patients will be randomised to receive either SEMS alone or SEMS with radiotherapy. The radiotherapy will be given as an outpatient either as five treatments (one per day) over one week, or ten treatments over two weeks. Questionnaires will be completed before treatment, and at weeks two and four and then monthly for up to one year to assess quality of life and cost effectiveness. Interviews will be held with trial participants at three time points to explore their experiences while on the trial. Interviews will also be held with patients who do not consent to take part in the trial to explore their reasons for non-consent.
Treatments:
Arm A: Self-expanding metal stents (SEMS) (Control Arm) SEMS insertion will be undertaken in accordance with standard local protocols. Covered or partially covered metal stents will be used and the length type and mode of stent placement will be selected by the clinician. Insertion will occur within two weeks of randomisation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological confirmation of oesophageal carcinoma excluding small cell histology
- •Not suitable for radical treatment (oesophagectomy or radical chemoradiotherapy) either because of patient choice or medical reasons
- •Dysphagia clinically assessed as needing stent as primary treatment of the dysphagia
- •Age 16 years or over
- •Discussion and treatment decision for stent placement made by an upper GI multi-disciplinary team
- •Clinician assessment of ability to attend for radiotherapy
- •Expected survival of at least 12 weeks
- •Written informed consent
- •Patient has completed baseline Quality of Life Questionnaires (please note, as a minimum patients must have completed OG25)
排除标准
- •Histology of small cell carcinoma type
- •Tumour length of greater than 12 cm
- •Tumour growth within 2 cm of the upper oesophageal sphincter
- •Endoscopic treatment of the tumour, other than dilatation, planned in the peri-stent period
- •Presence of a tracheo-oesophageal fistula
- •Presence of a pacemaker in proposed radiotherapy field
- •Previous radiotherapy to the area of the proposed radiotherapy field
- •Planned endoscopic treatment of the tumour (e.g. laser) in the immediate peri-stenting period
- •Female patient who is pregnant
研究组 & 干预措施
Arm A: Self-expanding metal stents (SEMS) (Control Arm)
SEMS insertion will be undertaken in accordance with standard local protocols. Covered or partially covered metal stents will be used and the length type and mode of stent placement will be selected by the clinician. Insertion will occur within two weeks of randomisation.
Arm B: SEMS plus external beam radiotherapy (Intervention Arm)
External beam radiotherapy (EBRT) is routinely available at regional cancer centres across the UK. For palliation of dysphagia in oesophageal cancer, a radiotherapy course delivering a tumour absorbed dose of 20Gy in 5 fractions or 30Gy in 10 fractions within 4 weeks of SEMS insertion.
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
patient-reported dysphagia
时间窗: within one year
Assess the impact of radiotherapy in addition to self-expanding metal stent (SEMS) placement on time to progression of patient-reported dysphagia in a patient population unable to undergo surgery.
次要结局
- morbidity(one year)
- re-intervention rate(one year)
- quality of life(within one year)
- overall survival(one year)
- cost(one year)
研究者
Lisette Nixon
Senior Trial Manager
Velindre NHS Trust