Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boston Scientific Corporation
With
Biocompatibles UK Ltd
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Must be male or female, 18 years of age or older, and of any ethnic or racial group
If primary tumor has not been resected, it must be clinically stable
Must have colorectal cancer with unresectable metastatic disease to the liver (unresectable unilobar or bilobar disease) who have disease progression in the liver with oxaliplatin or irinotecan based first line chemotherapy
Must be eligible to receive second-line standard-of-care chemotherapy with either 1) an oxaliplatin-based chemotherapy regimen, or 2) an irinotecan-based chemotherapy regimen
Must have baseline efficacy images with measurable target tumors in the liver according to RECIST 1.1 using standard imaging techniques taken within 28 days prior to randomization. Images must be taken after, or at the time of completion of first line chemotherapy
Tumor replacement \<50% of total liver volume
Current Eastern Cooperative Oncology Group (ECOG) of 0-1 through screening to first treatment on study
Will have completed the first line chemotherapy regimen at least 14 days prior to initiation of 2nd line chemotherapy under the protocol
Patient is willing to participate in the study and has signed the study informed consent
Serum creatinine ≤ 2.0 mg/dL
Serum bilirubin up to 1.2 x upper limit of normal
Albumin ≥ 3.0 g/dL
Must have neutrophil count \>1200/mm3 (1.2x109/L)
You may not be if
History of hepatic encephalopathy
Contraindications to angiography and selective visceral catheterization such as bleeding diathesis or coagulopathy that is not correctable by usual therapy of hemostatic agents (eg. closure device)
History of severe peripheral allergy or intolerance to contrast agents, narcotics, sedatives or atropine that cannot be managed medically
Presentation of pulmonary insufficiency or clinically evident chronic obstructive pulmonary disease
Cirrhosis or portal hypertension
Prior external beam radiation treatment to the liver
Prior intra-arterial liver directed therapy, including transcatheter arterial chemoembolization (TACE) or Y-90 microsphere therapy
Planned treatment with biological agents within 28 days prior to receiving TheraSphere
Planned liver directed therapy or radiation therapy
Intervention for, or compromise of, the Ampulla of Vater
Clinically evident ascites (trace ascites on imaging is acceptable)
Toxicities due to prior cancer therapy that have not resolved before the initiation of study treatment, if the Investigator determines that the continuing complication will compromise the safe treatment of the patient
Significant life-threatening extra-hepatic disease, including patients who are on dialysis, have unresolved diarrhea, have serious unresolved infections including patients who are known to be human immunodeficiency virus (HIV) positive or have acute hepatitis B virus (HBV) or hepatitis C virus (HCV)
confirmed extra-hepatic metastases. Limited indeterminate extra-hepatic lesions in the lung and/or lymph nodes are permitted (up to 5 lesions in the lung, with each individual lesion \<1 cm; any number of lymph nodes with each individual nodes \<1.5 cm)
Contraindications to the planned second line standard-of-care chemotherapy regimen
Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to randomization, and must not be breastfeeding and must agree to use contraceptive for duration of study.
Participation in a clinical trial with an investigational therapy within 30 days prior to randomization
Co-morbid disease or condition that would place the patient at undue risk and preclude safe use of TheraSphere treatment, in the Investigator's judgment
Clareo Health | Efficacy Evaluation of TheraSphere Following Failed First Line Chemotherapy in Metastatic Colorectal Cancer
