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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01721954




Registration number
NCT01721954
Ethics application status
Date submitted
26/10/2012
Date registered
6/11/2012

Titles & IDs
Public title
FOLFOX6m Plus SIR-Spheres Microspheres vs FOLFOX6m Alone in Patients With Liver Mets From Primary Colorectal Cancer
Scientific title
Assessment of Overall Survival of FOLFOX6m Plus SIR-Spheres Microspheres Versus FOLFOX6m Alone as First-line Treatment in Patients With Non-resectable Liver Metastases From Primary Colorectal Carcinoma in a Randomised Clinical Study
Secondary ID [1] 0 0
STX0112
Universal Trial Number (UTN)
Trial acronym
FOXFIREGlobal
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Active comparator: Control Arm - Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab repeated every two weeks until evidence of treatment failure.

Experimental: Experimental Arm - Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab plus SIR-Spheres microspheres.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
From date of randomization until the date of death from any cause assessed up 3 yrs 8 months
Secondary outcome [1] 0 0
Progression-free Survival
Timepoint [1] 0 0
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years 8 months.

Eligibility
Key inclusion criteria
* Age 18 years or older
* Willing and able to provide written informed consent
* Unequivocal and measurable CT evidence of liver metastases which are not treatable by surgical resection or local ablation
* Limited extra-hepatic metastases in the lung and/or lymph nodes are permitted (Lung: 5 lesions total, < 1 cm, or 1 single lesion of up to 1.7 cm; Lymph nodules in one single anatomic area (pelvis, abdomen or chest): any number, < 2 cm)
* All imaging evidence used as part of the screening process must be within 28 days
* Suitable for either treatment regimen
* WHO performance status 0-1
* Adequate hematological, renal and hepatic function
* Life expectancy of at least 3 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
* Evidence of ascites, cirrhosis, portal hypertension, main portal or venous involvement or thrombosis as determined by clinical or radiologic assessment
* Previous radiotherapy delivered to the liver
* Non-malignant disease that would render the patient unsuitable for treatment according to the protocol
* Peripheral neuropathy > grade 2 (NCI-CTC)
* Dose-limiting toxicity associated with previous adjuvant 5-FU or oxaliplatin chemotherapy
* Prior non-adjuvant chemotherapy for any malignancy. Adjuvant chemotherapy for colorectal cancer is permitted provided that it was completed more than 6 months before entry into the study
* Pregnant or breast feeding
* Concurrent or prior history of cancer other than adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix
* Allergy to contrast media that would preclude angiography of the hepatic arteries

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/02/2017
Sample size
Target
Accrual to date
Final
209
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Border Medical Oncology Research Unit - Albury
Recruitment hospital [2] 0 0
Gosford Hospital - Gosford
Recruitment hospital [3] 0 0
Southern Medical Day Care Centre - Wollongong
Recruitment hospital [4] 0 0
Royal Brisbane Hospital - Herston
Recruitment hospital [5] 0 0
Gold Coast Health Services District - Southport
Recruitment hospital [6] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [7] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [8] 0 0
Hobart Hospital - Hobart
Recruitment hospital [9] 0 0
Monash Medical Centre - Bentleigh East
Recruitment hospital [10] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [11] 0 0
Western Hospital - Footscray
Recruitment hospital [12] 0 0
Peninsula Oncology Centre - Frankston
Recruitment hospital [13] 0 0
South Eastern Hospital - Noble Park
Recruitment hospital [14] 0 0
Maroondah Hospital - Ringwood East
Recruitment hospital [15] 0 0
St. John of God Murdoch Hospital - Murdoch
Recruitment hospital [16] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [17] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2250 - Gosford
Recruitment postcode(s) [3] 0 0
2500 - Wollongong
Recruitment postcode(s) [4] 0 0
4029 - Herston
Recruitment postcode(s) [5] 0 0
4215 - Southport
Recruitment postcode(s) [6] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [7] 0 0
5000 - Adelaide
Recruitment postcode(s) [8] 0 0
7000 - Hobart
Recruitment postcode(s) [9] 0 0
3165 - Bentleigh East
Recruitment postcode(s) [10] 0 0
3128 - Box Hill
Recruitment postcode(s) [11] 0 0
3011 - Footscray
Recruitment postcode(s) [12] 0 0
3199 - Frankston
Recruitment postcode(s) [13] 0 0
3174 - Noble Park
Recruitment postcode(s) [14] 0 0
3135 - Ringwood East
Recruitment postcode(s) [15] 0 0
6150 - Murdoch
Recruitment postcode(s) [16] 0 0
6009 - Nedlands
Recruitment postcode(s) [17] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
State/province [2] 0 0
Florida
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United States of America
State/province [3] 0 0
Illinois
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United States of America
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Louisiana
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United States of America
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Maryland
Country [6] 0 0
United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Pennsylvania
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United States of America
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South Carolina
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United States of America
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Texas
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United States of America
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Utah
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United States of America
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Vermont
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United States of America
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West Virginia
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United States of America
State/province [14] 0 0
Wisconsin
Country [15] 0 0
Belgium
State/province [15] 0 0
Aalst
Country [16] 0 0
Belgium
State/province [16] 0 0
Brussels
Country [17] 0 0
Belgium
State/province [17] 0 0
Edegem
Country [18] 0 0
Belgium
State/province [18] 0 0
Gent
Country [19] 0 0
Belgium
State/province [19] 0 0
Liege
Country [20] 0 0
France
State/province [20] 0 0
Amiens Cedex 1
Country [21] 0 0
France
State/province [21] 0 0
Clichy Cedex
Country [22] 0 0
France
State/province [22] 0 0
Grenoble Cedex 9
Country [23] 0 0
France
State/province [23] 0 0
Paris
Country [24] 0 0
France
State/province [24] 0 0
Pessac
Country [25] 0 0
France
State/province [25] 0 0
Poitiers cedex
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France
State/province [26] 0 0
Rennes Cedex
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Germany
State/province [27] 0 0
Berlin
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Germany
State/province [28] 0 0
Heilbronn
Country [29] 0 0
Germany
State/province [29] 0 0
Karlsruhe
Country [30] 0 0
Germany
State/province [30] 0 0
Magdeburg
Country [31] 0 0
Germany
State/province [31] 0 0
Marburg
Country [32] 0 0
Germany
State/province [32] 0 0
Muenster
Country [33] 0 0
Germany
State/province [33] 0 0
Munchen
Country [34] 0 0
Germany
State/province [34] 0 0
Munich
Country [35] 0 0
Israel
State/province [35] 0 0
Haifa
Country [36] 0 0
Israel
State/province [36] 0 0
Jerusalem
Country [37] 0 0
Israel
State/province [37] 0 0
Tel Aviv
Country [38] 0 0
Israel
State/province [38] 0 0
Tel Hashomer
Country [39] 0 0
Italy
State/province [39] 0 0
Aosta
Country [40] 0 0
Italy
State/province [40] 0 0
Bergamo
Country [41] 0 0
Italy
State/province [41] 0 0
Bologna
Country [42] 0 0
Italy
State/province [42] 0 0
Cuneo
Country [43] 0 0
Italy
State/province [43] 0 0
Pisa
Country [44] 0 0
Korea, Republic of
State/province [44] 0 0
Seoul
Country [45] 0 0
New Zealand
State/province [45] 0 0
Wellington
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New Zealand
State/province [46] 0 0
Dunedin
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New Zealand
State/province [47] 0 0
Grafton
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New Zealand
State/province [48] 0 0
Palmerston North
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Portugal
State/province [49] 0 0
Porto
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Singapore
State/province [50] 0 0
Singapore
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Spain
State/province [51] 0 0
Madrid
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Spain
State/province [52] 0 0
Pamplona
Country [53] 0 0
Taiwan
State/province [53] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sirtex Medical
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal van Hazel GA, Heinemann V, Sharma NK, Findlay MP, ... [More Details]


Results are available at https://clinicaltrials.gov/study/NCT01721954