Phase I/II Trial of Neoadjuvant Conformal Radiotherapy Plus Sorafenib for Patients With Soft Tissue Sarcoma of the Extremity and Body Wall

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed soft tissue sarcoma located on the extremity or body wall
and meeting 1 of the following criteria:

- Intermediate- or high-grade disease > 5 cm in maximal dimension

- Low-grade disease > 8 cm in maximal dimension

- No evidence of regional or distant metastatic disease

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Hemoglobin ≥ 9.0 g/dL

- ANC ≥ 1,500/mm^3

- Platelets ≥ 100,000/mm^3

- Total bilirubin ≤ 1.5 mg/dL (unless elevated due to Gilbert's syndrome)

- AST and ALT ≤ 2.5 times upper limit of normal (ULN)

- Creatinine ≤ 1.5 times ULN

- INR < 1.5 or PT/PTT within normal limits

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception (men must use effective
contraception for ≥ 3 months after completion of study treatment)

- Able to swallow whole pills

- None of the following cardiac conditions:

- NYHA class III-IV congestive heart failure

- Unstable angina (i.e., anginal symptoms at rest)

- New-onset angina (beginning within the past 3 months)

- Myocardial infarction within the past 6 months

- History of cardiac ventricular arrhythmia requiring ongoing anti-arrhythmic
therapy

- Uncontrolled hypertension, defined as systolic BP > 150 mm Hg or diastolic BP >
90 mm Hg, despite optimal medical management

- No prior clinical or laboratory evidence of bleeding diathesis or coagulopathy

- No thrombotic or embolic events (e.g., cerebrovascular accident including transient
ischemic attacks) within the past 6 months

- No pulmonary hemorrhage or bleeding event ≥ CTCAE grade 2 within the past 4 weeks

- No other hemorrhage or bleeding event ≥ CTCAE grade 3 within the past 4 weeks

- No significant traumatic injury in the past 4 weeks

- No active malabsorption problem not controlled with medical therapy

- No active clinically serious infection > CTCAE grade 2

- No known HIV infection or chronic hepatitis B or C

- No known or suspected allergy to sorafenib tosylate or any agent given in this study

- No indwelling metal that would preclude patient from undergoing DCE-MRI

PRIOR CONCURRENT THERAPY:

- At least 4 weeks since prior major surgery

- No prior or other concurrent preoperative investigational treatment

- No other concurrent cancer-directed therapy

- No concurrent St. John's wort or rifampin