NCT01376453 - Pre-operative 5-Fluorouracil (5-FU) and Sorafenib With External Radiation in Locally Advanced Rectal Cancer | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

June 30, 2011

Primary Completion Date

November 30, 2014

Study Completion Date

March 31, 2016

Conditions

Rectal Cancer

Interventions

DRUG

Sorafenib

In addition to radiation and 5-FU, sorafenib will be taken by mouth daily every day until the last day of radiation. The dose of sorafenib will be one of the following: 200 mg every other day, 200 mg daily, 400 mg daily, or 800 mg daily

DRUG

5-Fluorouracil (5-FU)

5-FU will be delivered at a dose of 225 mg/m\^2 daily through a catheter in a large vein continuously until the last day of radiation.

RADIATION

Radiation

Radiation sessions will be daily, Monday through Friday, except for holidays.

Trial Locations (1)

33612

H. Lee Moffitt Cancer Center and Research Institute, Tampa