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

放疗 (RT) 或化疗放疗缓解晚期食管癌 (OC) 症状的随机研究

• 批准号: nhmrc : 291103
• 负责人: A/Pr Elaine Beller
• 金额: $ 15.76万
• 依托单位国家: 澳大利亚
• 项目类别: NHMRC Project Grants
• 财政年份: 2004
• 资助国家: 澳大利亚
• 起止时间: 2004-01-01 至 2007-12-31
• 项目状态: 已结题
• 来源: https://researchdata.edu.au/randomised-study-radiotherapy-cancer-oc/82819
• 关键词: Randomised; study; Radiotherapy; RT; ChemoRT

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.

食道癌（食道）通过使食道变窄并损害食物向胃的运动而引起吞咽问题（吞咽困难）。>90%的食管癌（OC）患者有吞咽困难。OC很常见，占所有癌症诊断的1%，但很少可治愈，80%的患者在就诊时患有食管以外的疾病。因此，总生存率很低，10%的患者在3年时存活。大多数人患有阻塞食道的疾病，因此大多数患者在接受死亡时都会出现吞咽困难。这既影响患者维持营养的能力，又影响生活质量（QoL）的所有方面。享受食物是一种生活的乐趣，无法吞咽食物，水和唾液会导致个人自尊的严重损失。缓解吞咽困难是治疗的最高优先级。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考虑这一点，而很少有科学数据来帮助他们做出决定。该试验采用简单的2组随机化，放疗（RT）35 Gy，分15次，与化疗（顺铂和氟尿嘧啶）相同。RT方案和化疗在澳大利亚通常用于这种癌症和其他癌症。这是世界上第一个前瞻性评估RT的试验，也是第一个比较增加化疗效果的试验。审判将：1。使用一组特定问题（EORTC-QLQ-C30+食管模块）建立一种评估所有OC患者吞咽困难和QoL的新方法。2.量化常见RT方案的反应和毒性。3.评估化疗的额外益处和毒性。4.评估患者和肿瘤因素，确定前景和对治疗的反应。5.为新的化疗药物和不同的RT时间表的试验提供基准。即使两组的效果相似，该试验也将指导管理并为无法治愈的患者提供信息。