Current Clinical Trials at UIHC: GI Oncology Protocols: Unresectable Metastatic Colorectal Ca.
James R. Howe, M.D.
Peer Review Status: Internally Peer
Reviewed
Objective:
Patients eligible for this study are those with unresectable colorectal liver metastases with documented colorectal primaries. No extrahepatic disease can be present, and there must be less than 70% liver involvement.
FUDR is used because 94-99% is extracted on first pass through the liver vs. only 19-55% of 5-FU, and therefore systemic toxicity is much diminished while maintaining high doses in the liver.
The addition of Dexamethasone has decreased the incidence of biliary sclerosis from 12 to 3%.
Previous trials have allowed for crossover from the infusaid arm to the systemic arm or had many untreated patients. This study will not have a crossover. Those randomized to receive a pump who don't get it for anatomical reasons will receive systemic therapy but be analyzed in the HAI group (to prevent selection bias, pts. are grouped into intent to treat groups).
They have selected a sample size of 340 pts., which will allow for detection of a 42% difference between groups with 90% power and alpha of 0.05 at 2 years.
Next Page | Previous Page | Section Top | Title Page