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Trial record 6 of 46 for:    SIR-Spheres

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

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ClinicalTrials.gov Identifier: NCT00724503
Recruitment Status : Completed
First Posted : July 29, 2008
Results First Posted : March 26, 2019
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Sirtex Medical

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.


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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 530 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
Actual Study Start Date : August 2006
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Arm Intervention/treatment
Experimental: mFOLFOX6 + SIRT
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 (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.

Other Names:
  • mFOLFOX6m + SIRT
  • SIR-Spheres Y-90 microspheres

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

Other Name: mFOLFOX6




Primary Outcome Measures :
  1. Progression-Free Survival (PFS) at Any Site [ Time Frame: 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 ]
    PFS defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as an increase in the sum of the longest diameters of ≥ 20% and an absolute increase in the sum of the longest diameters of ≥ 5 mm, or the appearance of a new lesion.


Secondary Outcome Measures :
  1. Percentage of Participants With Overall Response [ Time Frame: Through study completion, up to 60 months ]
    Tumour Response Rate per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR) - Disappearance of all target lesions which is confirmed if determined by two observations not less than 4 weeks apart; Partial Response (PR) - >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.



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

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 ClinicalTrials.gov identifier (NCT number): NCT00724503


  Show 111 Study Locations
Sponsors and Collaborators
Sirtex Medical
Investigators
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Principal Investigator: Peter Gibbs, MD Melbourne Health
Principal Investigator: Guy van Hazel, MD Mount Medical Centre

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sirtex Medical
ClinicalTrials.gov Identifier: NCT00724503     History of Changes
Other Study ID Numbers: STX0206
First Posted: July 29, 2008    Key Record Dates
Results First Posted: March 26, 2019
Last Update Posted: March 26, 2019
Last Verified: March 2019
Keywords provided by Sirtex Medical:
colon cancer
Colorectal carcinoma
liver metastases
SIR-Spheres microspheres
yttrium-90
FOLFOX
bevacizumab
metastatic colorectal cancer
Additional relevant MeSH terms:
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Carcinoma
Colorectal Neoplasms
Neoplasm Metastasis
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
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
Bevacizumab
Oxaliplatin
Fluorouracil
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites