Adjuvant Chemotherapies in Resectable Pancreatic Cancer
Australasian Gastro-Intestinal Trials Group (AGITG)
1,090 participants
Oct 1, 2002
Interventional
Conditions
Summary
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 the 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 the European group. This trial will determine if chemotherapy in addition to surgery increases disease-free and overall 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.
Eligibility
Plain Language Summary
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Interventions
Gemcitabine vs 5-FU/leucovorin
Locations(2)
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ACTRN12605000361606