Phase I/II Trial of Neoadjuvant Conformal Radiotherapy Plus Sorafenib for Patients With Soft Tissue Sarcoma of the Extremity and Body Wall
- To determine the maximum tolerated dose of sorafenib tosylate when combined with
conformal external beam radiotherapy prior to resection with curative intent in
patients with soft tissue sarcoma of the extremity or body wall. (Phase I)
- To determine the rate of near-complete (≥ 95% tumor necrosis) pathological response to
this regimen in these patients. (Phase II)
- To describe the toxicities associated with this regimen.
- To determine the rate of R0 (negative resection margin), R1 (microscopically positive
resection margin), and R2 (macroscopically positive resection margin) following this
- To determine the radiographic response rate to this regimen as defined by conventional
- To obtain preliminary data regarding local disease control, distant disease control,
progression-free survival, and overall survival with this regimen.
OUTLINE: This is a phase I dose-escalation study of sorafenib tosylate followed by a phase
Patients receive oral sorafenib tosylate twice daily on days 1-35 and undergo conformal
radiotherapy 5 days a week for 5 weeks.
Patients undergo dynamic contrast-enhanced MRI scanning at baseline and day 63 followed by
surgical resection on day 70.
After completion of study therapy, patients are followed every 4 months.
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Maximal-tolerated dose of sorafenib tosylate when combined with conformal radiotherapy (Phase I)
Robert Canter, MD
University of California, Davis
|University of California Davis Cancer Center||Sacramento, California 95817|