A Phase II Multi-Institutional Efficacy and Safety Study of Chemotherapy With Selective Internal Radiation Treatment Using Y-90 Microspheres (CHEMO-SIRT) in Patients With Colorectal Cancer Liver Metastasis
- Evaluate the tumor response, as measured by total tumor mass, carcinoembryonic antigen
(CEA) level, measurable tumor volume by CT scan, and metabolic response by positron
emission tomography (PET) scan, in patients with colorectal cancer metastatic to the
liver undergoing chemotherapy and selective internal radiation therapy (SIRT)
comprising yttrium Y 90 resin microspheres.
- Evaluate the hepatic toxicity of this regimen, as measured by ALT, alkaline
phosphatase, and bilirubin levels, in these patients.
- Evaluate the therapeutic efficacy of this regimen, using time to in-liver disease
progression as an end point, in these patients.
- Evaluate the therapeutic efficacy of this regimen, using down-staging to resectability
as an end point, in these patients.
OUTLINE: This is a multicenter study.
Patients receive 1 of the following chemotherapy regimens:
- FOLFOX6: Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2
hours on day 1. Patients also receive fluorouracil IV continously over 46 hours
beginning on day 1.
- FOLFIRI: Patients receive irinotecan hydrochloride IV over 1 hour and leucovorin
calcium IV over 2 hours on day 1. Patients also receive fluorouracil IV continuously
over 46 hours beginning on day 1.
- FUDR: Patients receive floxuridine IV continuously on days 1-14. In all chemotherapy
regimens, treatment repeats every 2 weeks for up to 8 courses in the absence of disease
progression or unacceptable toxicity.
Patients also undergo selective internal radiation therapy (SIRT) comprising yttrium Y 90
resin microspheres on day 2 of chemotherapy course 1 (for patients receiving FOLFOX6 or
FOLFIRI chemotherapy regimens) or on day 1, 2, 3, 4, or 5 of course 1 (for patients
receiving FUDR chemotherapy regimen). SIRT may repeat in week 10 or 12.
In week 18, patients may undergo surgery if down-staging has occurred or they may receive
After completion of study therapy, patients are followed every 3 months for up to 2 years.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Tumor response as measured by carcinoembryonic antigen (CEA) level, RECIST criteria, and positron emission tomography (PET) scan
Kenneth L. Pennington, MD
Goshen Health System
|Center for Cancer Care at Goshen General Hospital||Goshen, Indiana 46526|