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

Completed · Phase 3

Conditions studied: Colorectal Cancer Metastatic

In brief

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.

Key facts

Study ID

NCT01721954

Run by

Sirtex Medical

People needed

209

Starts

2013-05-01

Expected to finish

2017-02-28

Last updated by the study team

2019-11-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Orlando Health — Orlando, Florida, United States
• Memorial Healthcare — Pembroke Pines, Florida, United States
• University of Illinois Chicago — Chicago, Illinois, United States
• Adventist Midwest Health — Hinsdale, Illinois, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Roswell Park Cancer Center — Buffalo, New York, United States
• Lenox Hill Hospital — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Spartanburg Regional Healthcare / Gibbs Cancer Center — Spartanburg, South Carolina, United States
• Methodist Hospital Dallas — Dallas, Texas, United States
• St. Mark's Hospital — Salt Lake City, Utah, United States
• Fletcher Allen Health Care — Burlington, Vermont, United States
• West Virginia University Healthcare — Morgantown, West Virginia, United States
• Aurora St. Luke's Medical Center — Milwaukee, Wisconsin, United States
• Border Medical Oncology Research Unit — Albury, New South Wales, Australia
• Gosford Hospital — Gosford, New South Wales, Australia
• Southern Medical Day Care Centre — Wollongong, New South Wales, Australia
• Royal Brisbane Hospital — Herston, Queensland, Australia
• Gold Coast Health Services District — Southport, Queensland, Australia
• Princess Alexandra Hospital — Woolloongabba, Queensland, Australia
• Royal Adelaide Hospital — Adelaide, South Australia, Australia
• City of Hope — Duarte, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.