Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01721954




Registration number
NCT01721954
Ethics application status
Date submitted
26/10/2012
Date registered
6/11/2012
Date last updated
5/11/2019

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
Treatment: Drugs - FOLFOX6m
Treatment: Devices - SIR-Spheres microspheres

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.


Treatment: Drugs: FOLFOX6m


Treatment: Devices: SIR-Spheres microspheres
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Devices
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
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
South Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Utah
Country [12] 0 0
United States of America
State/province [12] 0 0
Vermont
Country [13] 0 0
United States of America
State/province [13] 0 0
West Virginia
Country [14] 0 0
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
Country [26] 0 0
France
State/province [26] 0 0
Rennes Cedex
Country [27] 0 0
Germany
State/province [27] 0 0
Berlin
Country [28] 0 0
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
Country [46] 0 0
New Zealand
State/province [46] 0 0
Dunedin
Country [47] 0 0
New Zealand
State/province [47] 0 0
Grafton
Country [48] 0 0
New Zealand
State/province [48] 0 0
Palmerston North
Country [49] 0 0
Portugal
State/province [49] 0 0
Porto
Country [50] 0 0
Singapore
State/province [50] 0 0
Singapore
Country [51] 0 0
Spain
State/province [51] 0 0
Madrid
Country [52] 0 0
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
This study is a randomized, multi-center study that will compare the efficacy and safety of
selective internal radiation therapy (SIRT) using SIR-Spheres microspheres plus a standard
chemotherapy regimen of FOLFOX6m versus FOLFOX6m alone as first-line therapy in patients with
non-resectable liver metastases from primary colorectal carcinoma.

Treatment with the biologic agent bevacizumab, if part of the standard of care at
participating institutions, is allowed within this study at the discretion of the
Investigator.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01721954
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01721954