A Randomised Phase III Study in Advanced Oesophageal Cancer to Compare Quality of Life and Palliation of Dysphagia in Patients Treated With Radiotherapy vs ChemoRadiotherapy.
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
- 25
- 主要终点
- Relief of dysphagia
研究概览
简要总结
To compare the treatment of gullet cancer with radiotherapy alone and assess the advantage and toxicity of adding chemotherapy. The hypothesis to be tested is as follows: That the addition of chemotherapy to a short course of radiation treatment improves the proportion of patients who achieve relief of dysphagia and improves quality of life compared to radiation alone in patients with advanced oesophageal cancer.
详细描述
Prospective radical treatment trials in oesophageal cancer have shown responses in both radiotherapy alone and radiotherapy when combined with chemotherapy. Retrospective studies show a response in the palliative setting to relieve dysphagia. The response, durability and quality of life end points have not been previously fully documented. This will be addressed by this trial.
Dysphagia is the commonest presenting symptom due to local disease obstructing the oesophagus. Difficulty eating not only affects the patient's ability to maintain nutrition, but also impacts on all areas of quality of life. Relief of dysphagia becomes the highest priority for treatment.
At the time of developing this protocol there were no randomised trials comparing chemo-radiotherapy and radiotherapy in the palliative setting.
Few studies have prospectively assessed quality of life data for patients with oesophageal cancer, and although toxicity and survival data is available, there is no long-term data on quality of life. This trial will assess quality of life in a consecutive manner using a standardised self-reporting measure of quality of life, and compare quality of life across two groups having different treatments.
Eligible patients are those with proven carcinoma of the oesophagus who are deemed not suitable for definitive radical treatment due to the advanced nature of disease, presence of metastases or intercurrent illness, who have symptomatic dysphagia requiring loco-regional palliation.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy proven Carcinoma of the oesophagus.
- •Not a candidate for radical/curative treatment due to the advanced nature of the disease, presence of metastases, or intercurrent illness. (It should be noted that, patients with mediastinal nodes and no more distant disease maybe suitable for radical treatment).
- •Symptomatic patients with dysphagia scores of ≥ 1 i.e. able to eat only some solids (see Mellow Scale appendix 1)
- •Performance status ECOG ≤ 2
- •Patients must begin treatment within 2 weeks of randomization.
- •Patient is at least 18 years old.
- •Adequate haematological function to undergo chemotherapy. Peripheral blood - Neutrophils > 1.5 x 10^9/L - Platelets > 100 x 10^9/L
- •Adequate renal function, Creatinine - Calculated clearance ≥ 50 ml/min
- •Patients capable of childbearing are using adequate contraception.
- •Written informed consent of patient.
排除标准
- •Previous mega-voltage external beam Radiotherapy or brachy-therapy delivered to the region of the chest.
- •Synchronous active malignancies.
- •Pregnant or lactating patients.
- •Patients unfit for any treatment component.
- •Tracheo-oesophageal fistula.
- •Stents in situ.
- •Previous chemotherapy for Oesophageal Cancer
- •CT scan of thorax and abdomen more than 8 weeks prior to randomization
- •Full Blood Count, Biochemistry (including creatinine) and creatinine clearance more than 2 weeks prior to randomization
研究组 & 干预措施
A: Radiotherapy
Radiotherapy alone
干预措施: Radiotherapy (Radiation)
B: Chemo-radiotherapy
Chemotherapy (Cisplatin + 5-Fluorouracil ) and Radiotherapy
干预措施: Cisplatin (Drug)
B: Chemo-radiotherapy
Chemotherapy (Cisplatin + 5-Fluorouracil ) and Radiotherapy
干预措施: Radiotherapy (Radiation)
B: Chemo-radiotherapy
Chemotherapy (Cisplatin + 5-Fluorouracil ) and Radiotherapy
干预措施: 5-Fluorouracil (Drug)
结局指标
主要结局
Relief of dysphagia
时间窗: This will be measured at nine weeks after the start of radiotherapy and must be maintained at the next review 4 weeks thereafter.
次要结局
- Dysphagia progression free survival.(This will be measured from randomisation to the time of first progression of dysphagia.)
- Quality of Life differences post treatment and at 3 months and 6 months.(post treatment and at 3 months and 6 months.)
- Acute and late toxicity.(Interim analyses planned at 110 pateints. Final analyses will occur after 5 years.)
- Survival.(Interim analyses planned at 110 pateints. Final analyses will occur after 5 years.)
- Time to achieving any response in dysphagia after treatment as measured by an improvement of at least 1 point on the 5 point dysphagia scale.(Interim analyses planned at 110 pateints. Final analyses will occur after 5 years.)
- Time to achieving a complete response i.e. dysphagia score of 0.(Interim analyses planned at 110 pateints. Final analyses will occur after 5 years.)
- Number of patients receiving secondary treatment (radiation, chemotherapy or stenting).(Interim analyses planned at 110 pateints. Final analyses will occur after 5 years.)