Randomised study of Radiotherapy (RT) or ChemoRT to palliate symptoms of advanced oesophageal cancer (OC)
Randomised study of Radiotherapy (RT) or ChemoRT to palliate symptoms of advanced oesophageal cancer (OC)
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
项目状态:
已结题
起止时间:
2004-01-01 至 2007-12-31
中文摘要
食道(食道)癌通过使食道变窄和妨碍食物进入胃部而引起吞咽问题(吞咽困难)。90%的食管癌(OC)患者有吞咽困难。胃癌很常见,占所有癌症诊断的1%,但很少能治愈,80%的患者在发病时病变不止于食道。因此,总体生存率很低,只有10%的患者存活至3年。大多数患者患有食道阻塞的疾病,因此大多数患者在面对死亡时都患有吞咽困难。这既影响患者维持营养的能力,也影响生活质量(QoL)的各个方面。享受食物是生活的一种乐趣,不能吞咽食物、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的情况下考虑这一点,以帮助他们做出决定。该试验采用简单的2组随机化,放疗(RT) 35Gy,分15组,与化疗(顺铂和氟尿嘧啶)相同。在澳大利亚,放疗和化疗都是治疗这种癌症和其他癌症的常用方法。这是世界上第一个前瞻性评估放疗的试验,也是第一个比较添加化疗效果的试验。试验将:- 1;建立一套评估所有OC患者吞咽困难和生活质量的新方法,采用一套特异性问题(EORTC-QLQ-C30+食道模块)。2. 量化常规放射治疗计划的反应和毒性。3. 评估化疗的额外益处和毒性。4. 评估患者和肿瘤因素决定预后和对治疗的反应。5. 为新的化疗药物和不同的放疗计划的试验提供了一个基准。该试验将指导管理,并为无法治愈的患者提供信息,即使两种药物的效果相似。
英文摘要
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.
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