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Trial registered on ANZCTR


Registration number
ACTRN12606000007538
Ethics application status
Approved
Date submitted
13/12/2005
Date registered
4/01/2006
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Phase 1/2 study of SIR-Spheres plus systemic chemotherapy with 5-fluorouracil, leucovorin and oxaliplatin in patients with liver metastases from colorectal carcinoma
Scientific title
A phase 1/2 study to test the safety and efficacy of a single implantation of SIR-Spheres plus systemic chemotherapy with FOLFOX4 in patients with liver metastases derived from colorectal carcinoma.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unresectable liver metastases from colorectal carcinoma 968 0
Condition category
Condition code
Cancer 1041 1041 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 1042 1042 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study is a multi-centre phase I/II dose-escalation study that aims to assess the safety and efficacy of a single implantation of SIR-Spheres when used in combination with systemic chemotherapy with FOLFOX4. Toxicity will be assessed after 3 cycles of treatment, at which stage the oxaliplatin will be escalated to full dose and the patients will go on receive a maximum of 12 cycles of chemotherapy. (The duration of the treatment cycles varies as it is based on the doctor's discretion. Ideally the treatment cycles would be 1 week of treatment and then 1 week of rest.)
Intervention code [1] 799 0
Treatment: Devices
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1392 0
Toxicity
Timepoint [1] 1392 0
Assessed using standard UICC criteria which will be assessed after patients have completed 12 cycles of chemotherapy.
Secondary outcome [1] 2459 0
Response rate
Timepoint [1] 2459 0
Assessed at the conclusion of protocol chemotherapy. Patients will conmplete QoL questionairres and have CT scans quarterly. Patients will be followed after the conclusion of protocol chemotherapy until such time as they progress or the trial is closed, which will be a minimum of 9 months after the enrolment of the last patient.
Secondary outcome [2] 2460 0
Time to progression of disease
Timepoint [2] 2460 0
Assessed at the conclusion of protocol chemotherapy. Patients will conmplete QoL questionairres and have CT scans quarterly. Patients will be followed after the conclusion of protocol chemotherapy until such time as they progress or the trial is closed, which will be a minimum of 9 months after the enrolment of the last patient.
Secondary outcome [3] 2461 0
Location of disease progression
Timepoint [3] 2461 0
Assessed at the conclusion of protocol chemotherapy. Patients will conmplete QoL questionairres and have CT scans quarterly. Patients will be followed after the conclusion of protocol chemotherapy until such time as they progress or the trial is closed, which will be a minimum of 9 months after the enrolment of the last patient.
Secondary outcome [4] 2462 0
Quality of life
Timepoint [4] 2462 0
Assessed at the conclusion of protocol chemotherapy. Patients will conmplete QoL questionairres and have CT scans quarterly. Patients will be followed after the conclusion of protocol chemotherapy until such time as they progress or the trial is closed, which will be a minimum of 9 months after the enrolment of the last patient.

Eligibility
Key inclusion criteria
Histologically confirmed adenocarcinoma of the colon or rectum. CT evidence of malignant metastases in the liver. Liver metastases not treatable by some other form of local ablation. Prior treatment for metastatic CRC is not allowedAdequate hepatic, renal and haematological 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 hypertensionCNS metastases Previous radiotherapy to the upper abdomenNon-malignant disease that would render the patient ineligible for treatmentEquivocal, immeasurable or unevaluable metastases in the liverHepatic arterial anatomy that would prevent administration of SIR-Spheres>20% arteriovenous lungshuntingDLT associated with previous 5FU chemotherapy.

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] 1140 0
Commercial sector/Industry
Name [1] 1140 0
Sirtex Medical Limited
Address [1] 1140 0
Country [1] 1140 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Sirtex Medical Limited
Address
Country
Australia
Secondary sponsor category [1] 997 0
Commercial sector/Industry
Name [1] 997 0
Sanofi-Aventis
Address [1] 997 0
Country [1] 997 0
France

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2461 0
Mount Hospital
Ethics committee address [1] 2461 0
Ethics committee country [1] 2461 0
Australia
Date submitted for ethics approval [1] 2461 0
Approval date [1] 2461 0
Ethics approval number [1] 2461 0
Ethics committee name [2] 2462 0
Leicester Royal Infirmary
Ethics committee address [2] 2462 0
Ethics committee country [2] 2462 0
Australia
Date submitted for ethics approval [2] 2462 0
Approval date [2] 2462 0
Ethics approval number [2] 2462 0
Ethics committee name [3] 2463 0
Epworth Hospital
Ethics committee address [3] 2463 0
Ethics committee country [3] 2463 0
Australia
Date submitted for ethics approval [3] 2463 0
Approval date [3] 2463 0
Ethics approval number [3] 2463 0
Ethics committee name [4] 2464 0
Nepean Hospital
Ethics committee address [4] 2464 0
Ethics committee country [4] 2464 0
Australia
Date submitted for ethics approval [4] 2464 0
Approval date [4] 2464 0
Ethics approval number [4] 2464 0

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

Contacts
Principal investigator
Name 27334 0
Address 27334 0
Country 27334 0
Phone 27334 0
Fax 27334 0
Email 27334 0
Contact person for public queries
Name 9988 0
Michael Tapner
Address 9988 0
Sirtec Medical Ltd
PO Box 760
North Ryde NSW 1670
Country 9988 0
Australia
Phone 9988 0
+61 2 99361426
Fax 9988 0
+61 2 99361404
Email 9988 0
mtapner@sirtex.com
Contact person for scientific queries
Name 916 0
Dr Guy van Hazel
Address 916 0
Perth Oncology
Mount Medical Centre
146 Mounts Bay Road
Perth WA 6000
Country 916 0
Australia
Phone 916 0
+61 8 94813072
Fax 916 0
Email 916 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