None listed
Conditions
Brief 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.
Interventions
Gemcitabine vs 5-FU/leucovorin
Sponsors
Australasian Gastro-Intestinal Trials Group (AGITG)
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who have undergone complete macroscopic resection for ductal adenocarcinoma of the pancreas (R0 or R1 resection) or patients with other cancers may be included who have had complete macroscopic resection (R0 or R1 resection) for (i) unusual malignancies of the pancreas, such as acinar cell carcinoma, cystadenocarcinoma etc.; (ii) cancers of the periampullary region; (iii) cancers of the intra-pancreatic part of the bile duct; (iv) periampullary cancers of uncertain origin. Patients with tumours as in 1(b) will be analysed separately and will be in addition to the recruitment of pancreatic cancer patients.* Histological confirmation of the primary diagnosis.* Histological examination of all resection margins.* No evidence of malignant ascites, liver metastasis, spread to other distant abdominal organs, peritoneal metastasis, spread to extra-abdominal organs.* WHO performance status < 2* Fully recovered from the operation and fit to take part in the trial. Life-expectancy of more than 3 months.* Able to attend for administration of the adjuvant therapy.* Able to attend for long-term follow-up.* No previous or concurrent malignancy diagnoses (except curatively-treated basal cell carcinoma of skin, carcinoma in situ of cervix).* No serious medical or psychological condition precluding adjuvant treatment.* Fully informed written consent given.
Exclusion criteria
* Use of neo-adjuvant chemotherapy or other concomitant chemotherapy. * Patients with pancreatic lymphoma. * Macroscopically remaining tumour (R2 resection) * Patients with TNM Stage IVb disease. * Patients younger than 18 years. * Pregnancy.
Outcome results
None listed