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

Phase 3

Completed

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Control Arm	FOLFOX6m	Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab repeated every two weeks until evidence of treatment failure.
Experimental Arm	FOLFOX6m	Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab plus SIR-Spheres microspheres.
Experimental Arm	SIR-Spheres microspheres	Systemic chemotherapy with FOLFOX6m plus or minus bevacizumab plus SIR-Spheres microspheres.

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	From date of randomization until the date of death from any cause assessed up 3 yrs 8 months	OS defined as the time interval between the date of randomization and the date of death from any cause.

Secondary Outcome Measures

Name	Time	Method
Progression-free Survival	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years 8 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.

Locations (83): City of Hope
🇺🇸
Duarte, California, United States
Orlando Health
🇺🇸
Orlando, Florida, United States
Memorial Healthcare
🇺🇸
Pembroke Pines, Florida, United States
University of Illinois Chicago
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Chicago, Illinois, United States
Adventist Midwest Health
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Hinsdale, Illinois, United States
Ochsner Clinic Foundation
🇺🇸
New Orleans, Louisiana, United States
University of Maryland Medical Center
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Baltimore, Maryland, United States
Montefiore Medical Center
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Bronx, New York, United States
Roswell Park Cancer Center
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Buffalo, New York, United States
Lenox Hill Hospital
🇺🇸
New York, New York, United States
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City of Hope
🇺🇸Duarte, California, United States