Randomised study of Radiotherapy (RT) or ChemoRT to palliate symptoms of advanced oesophageal cancer (OC)

食道癌(食道癌)会使食道变窄，影响食物流向胃，从而引起吞咽问题(吞咽困难)。90%的食道癌(OC)患者有吞咽困难。OC很常见，占所有癌症诊断的1%，但很少能治愈，80%的患者在表现时有食道以外的疾病。因此，总体存活率很低，仅有10%的患者在3年内存活。大多数患者有疾病阻塞食道，因此大多数患者在接受死亡时会出现吞咽困难。这既会影响患者维持营养的能力，也会影响生活质量的各个方面。享受食物是生活的一种乐趣，无法吞咽食物、水和唾液会导致个人自尊的严重丧失。缓解吞咽困难是治疗的重中之重。这必须与治疗的毒性相平衡。令人惊讶的是，患者和他们的医生必须在几乎没有科学数据帮助他们做出决定的情况下考虑这一点。该试验使用简单的双臂随机化，放射治疗(RT)35Gy15次，与化疗(顺铂和氟尿嘧啶)相同。在澳大利亚，RT计划和化疗都是这种癌症和其他癌症的常用治疗方法。这是世界上第一个前瞻性评估RT的试验，也是第一个比较化疗效果的试验。该试验将：-1.建立一种新的方法，使用一组特定的问题(EORTC-QLQ-C30+食道模块)来评估所有OC患者的吞咽困难和生活质量。2.量化普通RT方案的反应和毒性。3.评估化疗的额外益处和毒性。4.评估决定前景和治疗反应的患者和肿瘤因素。5.为新的化疗药物和不同的RT时间表的试验提供基准。这项试验将指导管理并为不治之症患者提供信息，即使这两个手臂的效果相似。

Cancer of the oesophagus (gullet) causes swallowing problems (dysphagia) by narrowing the gullet and harming food movement to the stomach. >90% of patients with oesophageal cancer (OC) have dysphagia. OC is common, representing >1% of all cancer diagnoses, but is rarely curable, >80% of patients having disease beyond the oesophagus at presentation. Overall survival is thus poor with <10% of patients alive at 3 years. Most have disease obstructing the gullet and thus most patients suffer dysphagia as they come to terms with dying. This affects both the patient's ability to maintain nutrition and impinges on all areas of quality of life (QoL). Enjoying food is a pleasure of life and an inability to swallow food, water and saliva causes a significant loss of personal self esteem. Relief of dysphagia is the highest priority for treatment. This must be balanced against toxicity of treatment. It is surprising that patients and their doctors must consider this with very little scientific data to help their decisions. The trial uses a simple 2 arm randomisation, radiotherapy (RT) 35Gy in 15 fractions, versus the same with chemotherapy (Cisplatin and Fluorouracil). Both the RT schedule and chemotherapy are commonly used in Australia for this and other cancers. This is the first trial in the world to prospectively assess RT and the first to compare the effect of adding chemotherapy. The trial will:- 1. establish a new method of assessing dysphagia and QoL in all patients with OC using a set of specific questions(EORTC-QLQ-C30+oesophageal module). 2. quantify response and toxicity of a common RT schedule. 3. evaluate the extra benefit and toxicities of chemotherapy. 4. evaluate patient and tumour factors determining outlook, and response to treatment. 5. provide a bench mark for trials of new chemotherapy agents and different RT schedules. The trial will guide management and provide information for incurable patients even if both arms are similar in their effect.