A Randomised Trial of Adjuvant Chemotherapies in Resectable Pancreatic Cancer: ESPAC-3

可切除胰腺癌辅助化疗的随机试验：ESPAC-3

• 批准号: nhmrc : 253743
• 负责人: Dr Haryana Dhillon
• 金额: $ 28.71万
• 依托单位国家: 澳大利亚
• 项目类别: NHMRC Project Grants
• 财政年份: 2003
• 资助国家: 澳大利亚
• 起止时间: 2003-01-01 至 2005-12-31
• 项目状态: 已结题
• 来源: https://researchdata.edu.au/randomised-trial-adjuvant-espac-3/97145
• 关键词: Randomised; Trial; Adjuvant; Chemotherapies; Resectable

Over 1,650 Australians are diagnosed with pancreatic cancer each year. In most cases, surgery will remove the tumour but it is possible that the cancer will return as a result of undetectable disease (micrometastases). The cancer will return and be incurable in the majority of patients. More than 1600 Australians die of the disease every year. This study compares the impact of adding chemotherapy to surgery alone (the current standard of care). The study will also compare the effectiveness of two different types of chemotherapy. Surgical resection of a pancreas tumour is the current standard of care for this disease. It is possible that people treated with chemotherapy after their tumour has been surgically removed may live longer before their disease returns and may liver longer overall. This has been shown to be true in other in cancers; eg. breast and bowel. The side effects of chemotherapy are important and can be severe in some people. Recent studies in advanced pancreatic cancer have suggested that the new drug gemcitabine may be more effective than other drugs. For this reason, the trial compares the outcomes in people treated with gemcitabine to those treated with an older drug 5FU, which has been shown to improve survival in an earlier study by a European group. This trial will determine if chemotherapy in addition to surgery increases the length of time before the disease comes back and survival. If it does, it should become standard practice. This study is an important international initiative that will provide unique information about effectiveness of these treatments and their impact on quality of life from the patient's perspective. This study and the previous European study are the largest of their type ever done. 900 people will take part. This study is being conducted in Australia by the Australasian Gastro-Intestinal Trials in collaboration with the Australian Hepatobilary Association and the NHMRC Clinical Trials Centre.

每年有超过1，650名澳大利亚人被诊断患有胰腺癌。在大多数情况下，手术将切除肿瘤，但由于无法检测到的疾病（微转移），癌症可能会复发。癌症会复发，并且在大多数患者中无法治愈。每年有1600多名澳大利亚人死于这种疾病。这项研究比较了在单独手术（目前的护理标准）基础上增加化疗的影响。该研究还将比较两种不同类型化疗的有效性。胰腺肿瘤的手术切除是目前治疗这种疾病的标准。在手术切除肿瘤后接受化疗的人可能会在疾病复发之前活得更长，并且总体上可能会活得更长。这在其他癌症中也被证明是正确的;例如。乳房和肠子化疗的副作用很重要，在某些人中可能很严重。最近对晚期胰腺癌的研究表明，新药吉西他滨可能比其他药物更有效。出于这个原因，该试验比较了使用吉西他滨治疗的患者与使用较老药物5 FU治疗的患者的结果，后者在欧洲一个小组的早期研究中已被证明可以提高生存率。这项试验将确定除了手术之外的化疗是否会增加疾病复发和生存的时间。如果是这样，它应该成为标准做法。这项研究是一项重要的国际倡议，将从患者的角度提供有关这些治疗的有效性及其对生活质量影响的独特信息。这项研究和以前的欧洲研究是有史以来规模最大的研究。将有900人参加。本研究由澳大利亚胃肠试验与澳大利亚肝胆协会和NHMRC临床试验中心合作在澳大利亚进行。