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

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 evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00724503
Recruitment Status : Completed
First Posted : July 29, 2008
Last Update Posted : January 30, 2017
Information provided by (Responsible Party):
Sirtex Medical

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Colorectal Carcinoma Liver Metastases Drug: Systemic chemotherapy (FOLFOX) Device: SIR-Spheres yttrium-90 microspheres Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 532 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : August 2006
Actual Primary Completion Date : June 2016
Actual Study Completion Date : November 2016

Arm Intervention/treatment
Active Comparator: A: FOLFOX alone
Systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5- Fluorouracil (FOLFOX)
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

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)
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

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00724503

  Show 137 Study Locations
Sponsors and Collaborators
Sirtex Medical
Principal Investigator: Peter Gibbs, MD Melbourne Health
Principal Investigator: Guy van Hazel, MD Mount Medical Centre

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Sirtex Medical Identifier: NCT00724503     History of Changes
Other Study ID Numbers: STX0206
First Posted: July 29, 2008    Key Record Dates
Last Update Posted: January 30, 2017
Last Verified: January 2017

Keywords provided by Sirtex Medical:
colon cancer
Colorectal carcinoma
liver metastases
SIR-Spheres microspheres
metastatic colorectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Liver Diseases
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs