FOLFOX Plus SIR-SPHERES MICROSPHERES Versus FOLFOX Alone in Patients With Liver Mets From Primary Colorectal Cancer (SIRFLOX)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sirtex Medical
ClinicalTrials.gov Identifier:
NCT00724503
First received: July 25, 2008
Last updated: May 28, 2013
Last verified: May 2013

July 25, 2008
May 28, 2013
August 2006
April 2014   (final data collection date for primary outcome measure)
progression free survival [ Time Frame: from randomisation until progressive disease is confirmed or upon patient death if disease progression has not been evident at that time ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00724503 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
FOLFOX Plus SIR-SPHERES MICROSPHERES Versus FOLFOX Alone in Patients With Liver Mets From Primary Colorectal Cancer
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

This study is a randomized multi-center trial that will assess the effect of adding 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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Colorectal Cancer
  • Colorectal Carcinoma
  • Liver Metastases
  • Drug: Systemic chemotherapy (FOLFOX)

    Oxaliplatin 85 mg/m2, IV infusion, q two weeks

    Leucovorin 200 mg/m2, IV infusion, q two weeks

    5-Fluorouracil 400 mg/m2, IV bolus, q two weeks

    5-Fluorouracil 2.4 g/m2, IV infusion, q two weeks

    Other Name: FOLFOX6m
  • Device: SIR-Spheres yttrium-90 microspheres
    SIR-Spheres microspheres implanted once on the 3rd or 4th day of the first week of the first chemotherapy cycle
    Other Names:
    • SIRT
    • SIR-Spheres Y-90 microspheres
  • Drug: Systemic chemotherapy (FOLFOX)

    Oxaliplatin 60 mg/m2,IV infusion, q two weeks for first 3 cycles

    Oxaliplatin 85 mg/m2, IV infusion, q two weeks from cycle 4 onwards

    Leucovorin 200 mg/m2, IV infusion, q two weeks

    5-Fluorouracil 400 mg/m2, IV bolus, q two weeks

    5-Fluorouracil 2.4 g/m2, IV infusion, q two weeks

    Other Name: FOLFOX6m
  • Active Comparator: A: FOLFOX alone
    Systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5- Fluorouracil (FOLFOX)
    Intervention: Drug: Systemic chemotherapy (FOLFOX)
  • Active Comparator: B: FOLFOX + SIR-Spheres
    A single injection of SIR-Spheres microspheres into the liver plus systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX)
    Interventions:
    • Device: SIR-Spheres yttrium-90 microspheres
    • Drug: Systemic chemotherapy (FOLFOX)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
518
April 2018
April 2014   (final data collection date for primary outcome measure)

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.

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   France,   Germany,   Israel,   Italy,   New Zealand,   Poland,   Spain,   Switzerland
 
NCT00724503
STX0206
Yes
Sirtex Medical
Sirtex Medical
Not Provided
Principal Investigator: Peter Gibbs, MD Melbourne Health
Principal Investigator: Guy van Hazel, MD Mount Medical Centre
Sirtex Medical
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP