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

Not Applicable

Completed

Interventions: Device: SIR-Spheres yttrium-90 microspheres
Drug: Systemic chemotherapy (FOLFOX)

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.

Recruitment & Eligibility

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.

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
mFOLFOX6 + SIRT	SIR-Spheres yttrium-90 microspheres	A single injection of SIR-Spheres microspheres into the liver plus systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX)
mFOLFOX6	Systemic chemotherapy (FOLFOX)	Systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5- Fluorouracil (FOLFOX).

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS) at Any Site	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

Name	Time	Method
Percentage of Participants With Overall Response	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.

Locations (111): Pinnacle Oncology Hematology
🇺🇸
Scottsdale, Arizona, United States
City of Hope Hospital
🇺🇸
Duarte, California, United States
Florida International University College of Medicine Practice
🇺🇸
North Miami Beach, Florida, United States
Vanguard Health
🇺🇸
Berwyn, Illinois, United States
University of Illinois at Chicago
🇺🇸
Chicago, Illinois, United States
Ingalls Memorial Hospital
🇺🇸
Harvey, Illinois, United States
Adventist Hinsdale Hospital
🇺🇸
Hinsdale, Illinois, United States
University of Louisville
🇺🇸
Louisville, Kentucky, United States
University of Maryland Medical Center
🇺🇸
Baltimore, Maryland, United States
William Beaumont Hospital
🇺🇸
Royal Oak, Michigan, United States
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Pinnacle Oncology Hematology
🇺🇸Scottsdale, Arizona, United States