None listed
Conditions
Brief summary
This study will evaluate the efficacy of Selective Internal Radiation (SIR) spheres in combination with chemotherapy for patients with pancreatic cancer with liver metastases. Who is it for? You may be eligible to participate in this study if you are aged 18 years or above and have been diagnosed with metastatic pancreatic cancer with liver metastases. Study details All participants in this study will receive standard chemotherapy care in combination with SIR sphere implant. Sir Spheres are injected via a catheter into the blood stream of the liver. The follow up assessments include physical exam, CT scans, and blood samples and urine samples. The study is designed to assess the ability of SIR spheres in combination with chemotherapy to control liver metastases from pancreatic cancer. As liver metastases are a major event impacting on survival, control of these metastases could result in an improvement in survival.
Interventions
SIR-Spheres microspheres are injected by a qualified radiologist via catheter into the blood stream of the liver. It is an once of treatment of radiotherapy and is designed to destroy cancer in the liver. The dose depends on the size of the liver tumour. The treatment takes 60-90mins and is administered concurrently with chemotherapy. Nab-Paclitaxel plus Gemcitabine are used as standard of care chemotherapy in this study.
Sponsors
Ringwood Private Hospital
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically or cytologically confirmed pancreatic adenocarcinoma with contrast CT/ PET evidence of measurable liver metastases. Low volume extra-hepatic metastases are permitted. 2. Liver metastases should be the dominant site of disease. Limited extra-hepatic metastases in the lung and/or lymph nodes are permitted. Metastases in the lung must either be not more than five nodules in number with no nodule more than 1 cm in diameter or one single lesion of up to 1.7 cm Involvement of lymph nodes in one single anatomic region (pelvis, abdomen or chest) is permitted provided their longest diameter measures less than 2 cm. 3. Baseline imaging used as a basis for PT entry within 29 days of PT entry. 4. Male or female aged 18 years or older. 5. Suitable for treatment as determined by clinical assessment undertaken by the Investigator. 6. Life expectancy of at least 2 months without any active treatment.
Exclusion criteria
1. Evidence of ascites or cirrhosis or portal hypertension as determined by clinical and radiological assessment. 2. Occlusion of the main portal vein or otherwise deemed unsuitable by the radiologist. 3. Central nervous system metastases as determined by CT or MRI scan. 4. Previous radiotherapy to the upper abdomen that included the liver in the treatment field. 5. Evidence of any concurrent condition that, in the opinion of the Investigator, would render the patient ineligible for treatment according to this protocol. 6. Hepatic arterial anatomy that would prevent the administration of SIR-Spheres into the liver 7. >20% arteriovenous lung shunting on a technetium99-MAA nuclear scan. 8. Female patients who are pregnant or breast-feeding.
Outcome results
None listed