Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000647538
Ethics application status
Not yet submitted
Date submitted
3/04/2015
Date registered
23/06/2015
Date last updated
23/06/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the efficacy of Selective Internal Radiation (SIR) spheres in combination with chemotherapy for patients with pancreatic cancer with liver metastases
Scientific title
Evaluating the efficacy of SIR-spheres in combination with chemotherapy for patients with pancreatic cancer with liver metastases
Secondary ID [1] 286475 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
metastatic pancreatic cancer 294662 0
Condition category
Condition code
Cancer 294964 294964 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 291561 0
Treatment: Devices
Comparator / control treatment
one arm only
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294720 0
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.
Timepoint [1] 294720 0
from time of SIR sphere implant to diagnosis of progressive disease of liver metastases (monitored 8 weekly until disease progression recorded or patient deceases)
Secondary outcome [1] 313926 0
Clinical Benefit Response: Toxicity and adverse events will be will be assessed using The National Cancer Institute Common Terminology.
Timepoint [1] 313926 0
assessed every 2 weeks from commencement of intervention for 18 weeks.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/07/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3655 0
Ringwood Private Hospital - East Ringwood

Funding & Sponsors
Funding source category [1] 291040 0
Hospital
Name [1] 291040 0
This is a investigator initiated trial by Ringwood Private Hospital.
Country [1] 291040 0
Australia
Primary sponsor type
Hospital
Name
Ringwood Private Hospital
Address
36 Mount Dandenong Road, Ringwood East

VIC 3135 Australia
Country
Australia
Secondary sponsor category [1] 289723 0
None
Name [1] 289723 0
none
Address [1] 289723 0
none
Country [1] 289723 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 292624 0
Bellberry Ethics Committee
Ethics committee address [1] 292624 0
129 Glen Osmond Road Eastwood South Australia 5063
Ethics committee country [1] 292624 0
Australia
Date submitted for ethics approval [1] 292624 0
21/04/2015
Approval date [1] 292624 0
Ethics approval number [1] 292624 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56294 0
Dr Prasad Cooray, Medical Oncologist
Address 56294 0
Ringwood Private Hospital
36 Mount Dandenong Road, Ringwood East
VIC 3135 Australia
Country 56294 0
Australia
Phone 56294 0
+61 (0) 3 9870 0079
Fax 56294 0
+61 (0) 3 8732 0228
Email 56294 0
prasad.cooray@icloud.com
Contact person for public queries
Name 56295 0
Prasad Cooray, Medical Oncologist
Address 56295 0
Ringwood Private Hospital
36 Mount Dandenong Road, Ringwood East
VIC 3135 Australia
Country 56295 0
Australia
Phone 56295 0
+61 (0) 3 9870 0079
Fax 56295 0
Email 56295 0
prasad.cooray@icloud.com
Contact person for scientific queries
Name 56296 0
Prasad Cooray, Medical Oncologist
Address 56296 0
Ringwood Private Hospital
36 Mount Dandenong Road, Ringwood East
VIC 3135 Australia
Country 56296 0
Australia
Phone 56296 0
+61 (0) 3 9870 0079
Fax 56296 0
Email 56296 0
prasad.cooray@icloud.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.