Clinical Trials
DOORwaY90 Study
*Using Common Terminology Criteria for Adverse Events v.5.0
BCLC, Barcelona Clinic Liver Cancer, ECOG, Easter Cooperative Oncology Group; EQ-5D-5L, EuroQoL 5-Dimensions 5-Level; FACT-Hep, Functional Assessment of Cancer Therapy-Hepatobiliary; HCC, hepatocellular carcinoma; LI-RADS, Liver Imaging Reporting And Data System; mRECIST, modified Response Evaluation Criteria in Solid Tumors; QoL, quality of life; SIRT, selective internal radiation therapy.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician Indications for Use: SIR-Spheres® Y-90 resin microspheres are indicated for the local tumor control of unresectable hepatocellular carcinoma (HCC) in patients with no macrovascular invasion, Child Pugh-A cirrhosis, well-compensated liver function, and good performance status. They are also indicated for the treatment of unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intra-hepatic artery chemotherapy (IHAC) of FUDR (Floxuridine). Side Effects: Common side effects are fever, transient decrease of hemoglobin, mild to moderate abnormality of liver function tests, abdominal pain, nausea, vomiting, and diarrhea. Potential serious effects due to exposure to high radiation include acute pancreatitis, radiation pneumonitis, acute gastritis, acute cholecystitis and radioembolization induced liver disease (REILD). Consult the Instructions for Use for a complete listing of indications, contraindications, side effects, warnings, and precautions.
BCLC, Barcelona Clinic Liver Cancer, ECOG, Easter Cooperative Oncology Group; EQ-5D-5L, EuroQoL 5-Dimensions 5-Level; FACT-Hep, Functional Assessment of Cancer Therapy-Hepatobiliary; HCC, hepatocellular carcinoma; LI-RADS, Liver Imaging Reporting And Data System; mRECIST, modified Response Evaluation Criteria in Solid Tumors; QoL, quality of life; SIRT, selective internal radiation therapy.