None listed
Conditions
Brief summary
Metatstatic pancreatic cancer is the 5th most lethal cancer killer. For those with hepatic lesions the outlook is 3-5 months with best available care. This study aims to use SIRT (Selective Internal Radiation Therapy) to effectively target and treat the hepatic lesions, thus significantly improving the outlook for patients with this condition.
Interventions
Patients will receive a single implant of SIR-Spheres microspheres followed by standard treatment with 5-fluorouracil (600 mg/m2) until disease progression or unacceptable toxicity. 4 to 6 weeks after implantation patients will receive gemcitabine (1000 mg/m2) weekly for seven weeks followed by a 1 week break. It will then be administered weekly for 3 weeks, followed by a 1 week break until disease progression or unacceptable toxicity.
Sponsors
Sirtex Medical Limited
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Pancreatic adenocarcinoma with contrast CT evidence of measurable liver metastases. Liver metastases should be the dominant site of disease and must be considered as impacting on patient QoL and/or survivalBaseline imaging must be <29 days of trial entry. Suitable for treatmentLife expectancy of at least 2 months without active treatmentPrior treatment of liver metastases is not allowed.Adequate Hematological, hepatic and renal function.WHO performance status 0-1.Willing and able to provide written informed consent.Female patients must be postmenopausal, sterile or using an acceptable method of contraception.
Exclusion criteria
Evidence of ascites, cirrhosis or portal hypertension as determined by clinical and radiological assessment.Occlusion of the main portal vein.Central nervous system metastases as determined by CT or MRI scan.Previous radiotherapy to the upper abdomen that included the liver in the treatment field.Evidence of any concurrent condition that would render the patient ineligible for treatment according to the protocol.Hepatic arterial anatomy that would prevent the administration of SIR-Spheres into the liver.>20% arteriovenous lung shunting on a technetium99 - MAA nuclear scan.Female patients who are pregnant or breastfeeding.Participation in a clinical trial of an investigational agent within 30 days of SIRT.
Outcome results
None listed