Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000015549
Ethics application status
Approved
Date submitted
9/01/2006
Date registered
10/01/2006
Date last updated
10/01/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
SIRT for metastatic pancreatic cancer
Scientific title
A phase I clinical trial to assess the efficacy of treatment with SIR-Spheres microspheres in patients with liver metastases from primary cancer of the pancreas
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic cancer with hepatic metastases 976 0
Condition category
Condition code
Cancer 1051 1051 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 826 0
Treatment: Devices
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1406 0
Time to progressive disease in the liver
Timepoint [1] 1406 0
Assessed every 8 weeks until progression is detected
Secondary outcome [1] 2480 0
Time to progressive disease at any site
Timepoint [1] 2480 0
Outcomes assessed monthly until progression is detected
Secondary outcome [2] 2481 0
Clinical Benefit Response
Timepoint [2] 2481 0
Outcomes assessed monthly until progression is detected
Secondary outcome [3] 2482 0
Response and stable disease rate (RECIST - CR, PR, SD)
Timepoint [3] 2482 0
Outcomes assessed monthly until progression is detected
Secondary outcome [4] 2483 0
Time to treatment failure
Timepoint [4] 2483 0
Outcomes assessed monthly until progression is detected
Secondary outcome [5] 2484 0
Site of progressive disease
Timepoint [5] 2484 0
Outcomes assessed monthly until progression is detected
Secondary outcome [6] 2485 0
Toxicity resulting from treatment with SIRT + chemotherapy
Timepoint [6] 2485 0
Outcomes assessed monthly until progression is detected
Secondary outcome [7] 2486 0
Survival
Timepoint [7] 2486 0
Outcomes assessed monthly until progression is detected

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1148 0
Commercial sector/Industry
Name [1] 1148 0
Sirtex Medical Limited
Country [1] 1148 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Sirtex Medical Limited
Address
Country
Australia
Secondary sponsor category [1] 1005 0
None
Name [1] 1005 0
none
Address [1] 1005 0
Country [1] 1005 0

Ethics approval
Ethics application status
Approved

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35843 0
Address 35843 0
Country 35843 0
Phone 35843 0
Fax 35843 0
Email 35843 0
Contact person for public queries
Name 10015 0
Michael Tapner
Address 10015 0
Sirtex Medical Limited
Unit F6
16 Mars Road
Lane Cove NSW 2066
Country 10015 0
Australia
Phone 10015 0
+61 2 99361426
Fax 10015 0
+61 2 99361404
Email 10015 0
mtapner@sirtex.com
Contact person for scientific queries
Name 943 0
Dr Peter Gibbs
Address 943 0
Oncology Department
Royal Melbourne Hospital
Parkville VIC 3050
Country 943 0
Australia
Phone 943 0
+61 3 93427560
Fax 943 0
+61 3 93477508
Email 943 0
Peter.Gibbs@mh.org.au

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
SourceTitleYear of PublicationDOI
Dimensions AIPhase II trial of selective internal radiation therapy and systemic chemotherapy for liver-predominant metastases from pancreatic adenocarcinoma2015https://doi.org/10.1186/s12885-015-1822-8
N.B. These documents automatically identified may not have been verified by the study sponsor.