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FOLFOX6m Plus SIR-Spheres Microspheres vs FOLFOX6m Alone in Patients With Liver Mets From Primary Colorectal Cancer (FOXFIREGlobal)

This study is currently recruiting participants.
Verified May 2013 by Sirtex Medical
Sponsor:
Information provided by (Responsible Party):
Sirtex Medical
ClinicalTrials.gov Identifier:
NCT01721954
First received: October 26, 2012
Last updated: May 9, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer Metastatic
 Drug: FOLFOX6m
Device: SIR-Spheres microspheres
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sirtex Medical:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: Time of randomization for an average of two years. ] [ Designated as safety issue: No ]
    To compare the effectiveness of treatment with SIRT using SIR-Spheres microspheres plus FOLFOX6m versus FOLFOX6m alone in terms of overall survival.


Secondary Outcome Measures:
  • Progression Free Survival [ Time Frame: Date of randomization for an average of 12 months. ] [ Designated as safety issue: No ]
    To compare the effectiveness of SIRT using SIR-Spheres microspheres plus FOLFOX6m versus FOLFOX6m alone.


Estimated Enrollment: 200
Study Start Date: February 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control Arm
Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab repeated every two weeks until evidence of treatment failure.
 Drug: FOLFOX6m
Experimental: Experimental Arm
Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab plus SIR-Spheres microspheres.
 Drug: FOLFOX6m Device: SIR-Spheres microspheres

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01721954

Contacts
Contact: Henk Tissing 31-26-3391124 htissing@sirtex-europe.com
Contact: Janet Bell 888-474-7839 ext 710 jbell@sirtex.com

  Show 78 Study Locations
Sponsors and Collaborators
Sirtex Medical
  More Information

No publications provided

Responsible Party: Sirtex Medical
ClinicalTrials.gov Identifier: NCT01721954     History of Changes
Other Study ID Numbers: STX0112
Study First Received: October 26, 2012
Last Updated: May 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Sirtex Medical:
colon
rectum
metastatic colorectal cancer
liver metastases

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasms
Neoplasms, Second Primary
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 19, 2013