Evaluating the efficacy of Selective Internal Radiation (SIR) spheres in combination with chemotherapy for patients with pancreatic cancer with liver metastases

• Conditions: metastatic pancreatic cancer; Cancer - Pancreatic

• Registration Number: ACTRN12615000647538
• Lead Sponsor: Ringwood Private Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-23
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Median time to progressive disease for the liver metastases. Progressive disease will be assessed according to RECIST 1.1 every 8 weeks using CT scans.[from time of SIR sphere implant to diagnosis of progressive disease of liver metastases (monitored 8 weekly until disease progression recorded or patient deceases)<br>]

Secondary Outcome Measures

Name	Time	Method
Clinical Benefit Response: Toxicity and adverse events will be will be assessed using The National Cancer Institute Common Terminology.<br>[assessed every 2 weeks from commencement of intervention for 18 weeks.]