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Neoadjuvant Sorafenib + Radiotherapy in Soft Tissue Sarcoma
NCT00864032Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2009
- Primary completion
- Aug 2011
- Countries
- 1
- Sponsor
- University of California, Davis
- Modality
- Small Molecules
- Drugs
- sorafenib
- Conditions
- soft tissue sarcoma (STS)
01
Overview
Phase 2, open-label, single-arm trial of sorafenib in soft tissue sarcoma (STS), sponsored by University of California, Davis. Primary endpoint: Number of Dose Limiting Toxicities at 12 weeks. Started Mar 2009; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Phase I/II
Sorafenib + Radiotherapy followed by Surgery
03
Who it enrols
Adult patients with histologically confirmed, localized, large (>5cm high grade or >8cm low grade) soft tissue sarcoma of the extremity or body wall, with adequate organ function and no metastatic disease.
04
Endpoints
Primary
Number of Dose Limiting Toxicities
Secondary
Pathologic Near-Complete/Complete Response Rate
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