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Trial registered on ANZCTR


Registration number
ACTRN12606000009516
Ethics application status
Approved
Date submitted
13/12/2005
Date registered
4/01/2006
Date last updated
4/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pilot study of SIR-Spheres plus systemic chemotherapy with irinotecan alone in patients with non-resectable liver metastases from primary adenocarcinoma of the large bowel
Scientific title
Phase I/II study to test safety and efficacy of SIR-Spheres plus systemic chemotherapy with irinotecan in patients with non-resectable liver metastases from primary adenocarcinoma of the large bowel.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic colorectal cancer 970 0
Condition category
Condition code
Cancer 1044 1044 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This dose escalation study is designed to assess the safety and efficacy of a single dose of SIR-Spheres when used in combination with irinotecan over a 9 treatment cycle duration. Each 3 week cycle of treatment with irinotecan on days 1 and 8 followed by a rest week on day 15.
Intervention code [1] 800 0
Treatment: Devices
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1397 0
Toxicity
Timepoint [1] 1397 0
Assessed over the duration of treatment and up to 1 month after the conclusion of protocol chemotherapy using UICC criteria
Primary outcome [2] 1398 0
Response Rate
Timepoint [2] 1398 0
Assessed up until the scan following the completion of protocol chemotherapy
Secondary outcome [1] 2466 0
Time to progressive disease
Timepoint [1] 2466 0
Secondary outcome [2] 2467 0
Site of Progressive Disease
Timepoint [2] 2467 0
Secondary outcome [3] 2468 0
Survival
Timepoint [3] 2468 0

Eligibility
Key inclusion criteria
Histologically confirmed primary adenocarcinoma of the large bowelCT evidence of metastases in the liverLiver metastases not treatable by some form of local ablation. Prior treatment with 5FU based chemotherapy permissible for the irinotecan alone armAdequate haematological, renal and hepatic functionWHO performance status 0-2Willing and able to provide written informed consent.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant or breast feedingEvidence of ascites, cirrhosis or portal hypertension as determined by clinical assessmentCNS metastasesPrevious radiotherapy to the liverimmeasurable or unevaluable metastases to the liverHepatic arterial anatomy that will prevent administration of SIR-Spheres>20% atreriovenous lung shuntingTreatment with capecitabine within 8 weeks 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
Phase 1 / Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1142 0
Commercial sector/Industry
Name [1] 1142 0
Sirtex Medical Limited
Address [1] 1142 0
Country [1] 1142 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Sirtex Medical Limited
Address
Country
Australia
Secondary sponsor category [1] 999 0
None
Name [1] 999 0
None
Address [1] 999 0
Country [1] 999 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2465 0
Mount Hospital
Ethics committee address [1] 2465 0
Ethics committee country [1] 2465 0
Australia
Date submitted for ethics approval [1] 2465 0
Approval date [1] 2465 0
Ethics approval number [1] 2465 0
Ethics committee name [2] 2466 0
Greenslopes Hospital
Ethics committee address [2] 2466 0
Ethics committee country [2] 2466 0
Australia
Date submitted for ethics approval [2] 2466 0
Approval date [2] 2466 0
Ethics approval number [2] 2466 0
Ethics committee name [3] 2467 0
Royal North Shore Hospital
Ethics committee address [3] 2467 0
Ethics committee country [3] 2467 0
Australia
Date submitted for ethics approval [3] 2467 0
Approval date [3] 2467 0
Ethics approval number [3] 2467 0
Ethics committee name [4] 2468 0
Prince of Wales Hospital
Ethics committee address [4] 2468 0
Ethics committee country [4] 2468 0
Australia
Date submitted for ethics approval [4] 2468 0
Approval date [4] 2468 0
Ethics approval number [4] 2468 0
Ethics committee name [5] 2469 0
Royal Adelaide Hospital
Ethics committee address [5] 2469 0
Ethics committee country [5] 2469 0
Australia
Date submitted for ethics approval [5] 2469 0
Approval date [5] 2469 0
Ethics approval number [5] 2469 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36191 0
Address 36191 0
Country 36191 0
Phone 36191 0
Fax 36191 0
Email 36191 0
Contact person for public queries
Name 9989 0
Michael Tapner
Address 9989 0
Sirtex Medical Ltd
PO Box 760
North Ryde NSW 1670
Country 9989 0
Australia
Phone 9989 0
+61 2 99361426
Fax 9989 0
+61 2 99361404
Email 9989 0
mtapner@sirtex.com
Contact person for scientific queries
Name 917 0
Dr Guy van Hazel
Address 917 0
Perth Oncology
Mount Medical Centre
146 Mounts Bay Road
Perth WA 6000
Country 917 0
Australia
Phone 917 0
+61 8 94813072
Fax 917 0
Email 917 0
guy@perthoncology.com.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary