Phase I/II Trial of Radiation Therapy and Sorafenib for Treatment of Unresectable Liver Metastases
In this study, Stereotactic Body Radiation Therapy(SBRT) and Whole Liver Radiotherapy (WLRT)
will be used concurrently with sorafenib at 3 different dosages to determine the
tolerability and efficacy of this combined treatment. Sorafenib doses will be 200mg twice
daily orally for 28 days in level I, 400 mg in the morning and 200mg in the evening in level
II, and 400mg twice daily orally for 28 days in level III . Radiotherapy will be started at
day 8, patients will receive a total of 6 fractions over 2 weeks. Patients will be assessed
weekly during treatment, 1 month post-tx, then at 3-month intervals for up to a year after
tx, and then followed-up at 6-month intervals up to 3 years. Once the Maximum Tolerated
Dose (MTD) is established, an expanded cohort for each stratum will accrue such that a total
of 10 patients per strata. This will allow us to gain further experience with this regimen
and consolidate the safety and efficacy data. Quality of Life (QOL) assessment will be
carried out at baseline and 1/3/6/9 mos post-tx. Patients will also be offered correlative
studies looking at biomarkers through tissue, blood, and urine samples, and an imaging study
looking at tissue perfusion.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the MTD of sorafenib and RT in patients with liver metastases using an iso-toxicity radiation dose allocation scheme. Determine the acute toxicity (< 3 months) of sorafenib when combined with RT in patients with liver metastases.
2 years enrollment; 3 years follow-up
Yes
Canada: Ethics Review Committee
UHN REB 08-0598-C
NCT00892424
November 2008
January 2015
Name | Location |
---|