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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00724503




Registration number
NCT00724503
Ethics application status
Date submitted
25/07/2008
Date registered
29/07/2008
Date last updated
26/03/2019

Titles & IDs
Public title
FOLFOX Plus SIR-SPHERES MICROSPHERES Versus FOLFOX Alone in Patients With Liver Mets From Primary Colorectal Cancer
Scientific title
Randomised Comparative Study Of Folfox6m Plus Sir-Spheres® Microspheres Versus Folfox6m Alone As First Line Treatment In Patients With Nonresectable Liver Metastases From Primary Colorectal Carcinoma
Secondary ID [1] 0 0
STX0206
Universal Trial Number (UTN)
Trial acronym
SIRFLOX
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer 0 0
Colorectal Carcinoma 0 0
Liver Metastases 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 0 0 0 0
Liver
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - SIR-Spheres yttrium-90 microspheres
Treatment: Drugs - Systemic chemotherapy (FOLFOX)

Experimental: mFOLFOX6 + SIRT - A single injection of SIR-Spheres microspheres into the liver plus systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX)

Active Comparator: mFOLFOX6 - Systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5- Fluorouracil (FOLFOX).


Treatment: Devices: SIR-Spheres yttrium-90 microspheres
SIR-Spheres microspheres (yttrium-90 [Y-90] labelled resin microspheres), hepatic artery injection administered on Day 3 or 4 of cycle 1.
mFOLFOX6 administered on Day 1 and at the start of each cycle every 14 days: 85 or 60 mg/m2 oxaliplatin by 2-hour intravenous (IV) infusion + 200 mg/m2 leucovorin by 2-hour IV infusion + 400 mg/m2 5-fluorouracil (5-FU) by IV bolus + 2.4 g/m2 5-FU by 46-hour continuous IV infusion.
Treatment with the biologic agent bevacizumab, if part of standard practice at the participating institution, was permitted at the discretion of the treating Investigator.
In the event that leucovorin was not available, use of levofolinic acid (the active S enantiomer) was acceptable at half the dose of the racemic leucovorin i.e. 100 mg/m2.

Treatment: Drugs: Systemic chemotherapy (FOLFOX)
mFOLFOX6 administered on Day 1 and at the start of each cycle every 14 days: 85 or 60 mg/m2 oxaliplatin by 2-hour intravenous (IV) infusion + 200 mg/m2 leucovorin by 2-hour IV infusion + 400 mg/m2 5-fluorouracil (5-FU) by IV bolus + 2.4 g/m2 5-FU by 46-hour continuous IV infusion.
Treatment with the biologic agent bevacizumab, if part of standard practice at the participating institution, was permitted at the discretion of the treating Investigator.
In the event that leucovorin was not available, use of levofolinic acid (the active S enantiomer) was acceptable at half the dose of the racemic leucovorin i.e. 100 mg/m2.
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS) at Any Site
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 60 months
Secondary outcome [1] 0 0
Percentage of Participants With Overall Response
Timepoint [1] 0 0
Through study completion, up to 60 months

Eligibility
Key inclusion criteria
- 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).

- Suitable for either treatment regimen.

- Prior chemotherapy for metastatic colorectal cancer is not allowed.

- WHO performance status 0-1.

- Adequate hematological, renal and hepatic function.

- Age 18 years or older.

- Willing and able to provide written informed consent.

- 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
Exclusion Criteria

- Evidence of ascites, cirrhosis, portal hypertension, main portal or venous tumor
involvement or thrombosis as determined by clinical or radiologic assessment.

- Previous radiotherapy delivered to the upper abdomen.

- Non-malignant disease that would render the patient unsuitable for treatment according
to the protocol.

- Peripheral neuropathy > grade 1 (NCI-CTC).

- Dose limiting toxicity with previous adjuvant 5-FU or oxaliplatin chemotherapy.

- Prior non-adjuvant chemotherapy for any malignancy. Adjuvant chemotherapy for
colorectal cancer is not an exclusion criteria provided that it was completed more
than 6 months before entry into the study.

- Pregnant or breast-feeding.

- Other active malignancy.

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
Not Applicable
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
1/08/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2015
Sample size
Target
Accrual to date
Final
530
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Concord Hospital - Concord
Recruitment hospital [2] 0 0
St. Vincent's Hospital - Darlinghurst
Recruitment hospital [3] 0 0
Nepean Cancer Care Centre - Kingswood
Recruitment hospital [4] 0 0
St. George Hospital - Kogarah
Recruitment hospital [5] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [6] 0 0
Sydney Adventist Hospital - Wahroonga
Recruitment hospital [7] 0 0
Westmead Hospital - Westmead
Recruitment hospital [8] 0 0
Wesley Medical Centre - Auchenflower
Recruitment hospital [9] 0 0
Cairns Private Hospital - Cairns
Recruitment hospital [10] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [11] 0 0
Gold Coast Health Service District - Southport
Recruitment hospital [12] 0 0
HOCA Gold Coast Centre - Southport
Recruitment hospital [13] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [14] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [15] 0 0
Ashford Cancer Centre - Ashford
Recruitment hospital [16] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [17] 0 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [18] 0 0
Queen Elizabeth II Hospital - Woodville South
Recruitment hospital [19] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [20] 0 0
Monash Medical Centre - Bentleigh East
Recruitment hospital [21] 0 0
John Fawkner Private Hospital - Coburg
Recruitment hospital [22] 0 0
Western Hospital - Footscray
Recruitment hospital [23] 0 0
Peninsula Oncology Centre - Frankston
Recruitment hospital [24] 0 0
South Eastern Private - Noble Park
Recruitment hospital [25] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [26] 0 0
Maroondah Public - Ringwood East
Recruitment hospital [27] 0 0
Ringwood/Knox Private - Ringwood
Recruitment hospital [28] 0 0
Hollywood Private Hospital - Nedlands
Recruitment hospital [29] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [30] 0 0
Mount Medical Centre - Perth
Recruitment hospital [31] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
- Kingswood
Recruitment postcode(s) [4] 0 0
2217 - Kogarah
Recruitment postcode(s) [5] 0 0
2065 - St Leonards
Recruitment postcode(s) [6] 0 0
2076 - Wahroonga
Recruitment postcode(s) [7] 0 0
2145 - Westmead
Recruitment postcode(s) [8] 0 0
4066 - Auchenflower
Recruitment postcode(s) [9] 0 0
4870 - Cairns
Recruitment postcode(s) [10] 0 0
4029 - Herston
Recruitment postcode(s) [11] 0 0
4215 - Southport
Recruitment postcode(s) [12] 0 0
- Woolloongabba
Recruitment postcode(s) [13] 0 0
- Adelaide
Recruitment postcode(s) [14] 0 0
- Ashford
Recruitment postcode(s) [15] 0 0
- Bedford Park
Recruitment postcode(s) [16] 0 0
5012 - Elizabeth Vale
Recruitment postcode(s) [17] 0 0
- Woodville South
Recruitment postcode(s) [18] 0 0
7000 - Hobart
Recruitment postcode(s) [19] 0 0
- Bentleigh East
Recruitment postcode(s) [20] 0 0
3058 - Coburg
Recruitment postcode(s) [21] 0 0
3011 - Footscray
Recruitment postcode(s) [22] 0 0
3199 - Frankston
Recruitment postcode(s) [23] 0 0
3174 - Noble Park
Recruitment postcode(s) [24] 0 0
3050 - Parkville
Recruitment postcode(s) [25] 0 0
3135 - Ringwood East
Recruitment postcode(s) [26] 0 0
3135 - Ringwood
Recruitment postcode(s) [27] 0 0
6009 - Nedlands
Recruitment postcode(s) [28] 0 0
- Nedlands
Recruitment postcode(s) [29] 0 0
6005 - Perth
Recruitment postcode(s) [30] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
North Dakota
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Utah
Country [15] 0 0
United States of America
State/province [15] 0 0
Washington
Country [16] 0 0
United States of America
State/province [16] 0 0
Wisconsin
Country [17] 0 0
Belgium
State/province [17] 0 0
Aalst
Country [18] 0 0
Belgium
State/province [18] 0 0
Antwerpen
Country [19] 0 0
Belgium
State/province [19] 0 0
Antwerp
Country [20] 0 0
Belgium
State/province [20] 0 0
Bonheiden
Country [21] 0 0
Belgium
State/province [21] 0 0
Bornem
Country [22] 0 0
Belgium
State/province [22] 0 0
Brussels
Country [23] 0 0
Belgium
State/province [23] 0 0
Gent
Country [24] 0 0
Belgium
State/province [24] 0 0
Haine-Saint-Paul
Country [25] 0 0
Belgium
State/province [25] 0 0
Leuven
Country [26] 0 0
Belgium
State/province [26] 0 0
Liege
Country [27] 0 0
Belgium
State/province [27] 0 0
Mechelen
Country [28] 0 0
Belgium
State/province [28] 0 0
Reet
Country [29] 0 0
Belgium
State/province [29] 0 0
Wilrijk
Country [30] 0 0
France
State/province [30] 0 0
Bordeaux
Country [31] 0 0
France
State/province [31] 0 0
La Tronche
Country [32] 0 0
France
State/province [32] 0 0
Longjumeau
Country [33] 0 0
France
State/province [33] 0 0
Nice
Country [34] 0 0
France
State/province [34] 0 0
Paris
Country [35] 0 0
France
State/province [35] 0 0
Rennes Cedex
Country [36] 0 0
Germany
State/province [36] 0 0
Altstadt
Country [37] 0 0
Germany
State/province [37] 0 0
Berlin
Country [38] 0 0
Germany
State/province [38] 0 0
Bonn
Country [39] 0 0
Germany
State/province [39] 0 0
Essen
Country [40] 0 0
Germany
State/province [40] 0 0
Frankfurt
Country [41] 0 0
Germany
State/province [41] 0 0
Hamburg
Country [42] 0 0
Germany
State/province [42] 0 0
Holzkirch
Country [43] 0 0
Germany
State/province [43] 0 0
Ingolstadt
Country [44] 0 0
Germany
State/province [44] 0 0
Karlsruhe
Country [45] 0 0
Germany
State/province [45] 0 0
Magdeburg
Country [46] 0 0
Germany
State/province [46] 0 0
Marburg
Country [47] 0 0
Germany
State/province [47] 0 0
Muenchen
Country [48] 0 0
Germany
State/province [48] 0 0
Munchen
Country [49] 0 0
Germany
State/province [49] 0 0
Velbert
Country [50] 0 0
Germany
State/province [50] 0 0
Weilheim
Country [51] 0 0
Israel
State/province [51] 0 0
Haifa
Country [52] 0 0
Israel
State/province [52] 0 0
Jerusalem
Country [53] 0 0
Israel
State/province [53] 0 0
Petah Tiqva
Country [54] 0 0
Israel
State/province [54] 0 0
Ramat Gan
Country [55] 0 0
Israel
State/province [55] 0 0
Tel Aviv
Country [56] 0 0
Italy
State/province [56] 0 0
Bologna
Country [57] 0 0
New Zealand
State/province [57] 0 0
Auckland
Country [58] 0 0
New Zealand
State/province [58] 0 0
Christchurch
Country [59] 0 0
New Zealand
State/province [59] 0 0
Dunedin
Country [60] 0 0
New Zealand
State/province [60] 0 0
Newtown
Country [61] 0 0
New Zealand
State/province [61] 0 0
Palmerston
Country [62] 0 0
Poland
State/province [62] 0 0
Warsaw
Country [63] 0 0
Spain
State/province [63] 0 0
Pamplona
Country [64] 0 0
Switzerland
State/province [64] 0 0
Zurich

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 trial that will assess the effect of adding Selective
Internal Radiation Therapy (SIRT), using SIR-Spheres microspheres®, to a standard
chemotherapy regimen of FOLFOX as first line therapy in patients with non-resectable liver
metastases from primary colorectal adenocarcinoma.

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 treating
Investigator.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00724503
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Peter Gibbs, MD
Address 0 0
Melbourne Health
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