A Phase II Trial of Image Guided Preoperative Radiotherapy for Primary Soft Tissue Sarcomas of the Extremity

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed primary soft tissue sarcoma of the upper extremity
(including shoulder) or lower extremity (including hip)

- Incisional or core biopsy required within the past 8 weeks

- No histopathological diagnosis of any of the following:

- Rhabdomyosarcoma

- Extraosseous primitive neuroectodermal tumor (PNET)

- Soft tissue Ewing sarcoma

- Osteosarcoma

- Kaposi sarcoma

- Angiosarcoma

- Aggressive fibromatosis (desmoid tumor)

- Dermatofibrosarcoma protuberans

- Chondrosarcoma

- Extraskeletal myxoid chondrosarcoma allowed

- Tumor must be surgically resectable, as determined by a surgeon within the past 8
weeks

- Limb-preservation surgery alone would not provide adequate local control, as
determined by the surgeon

- No sarcoma of the hand, foot, head, neck, or intra-abdominal or retroperitoneal
region or body wall

- No sarcoma ≥ 32 cm in any direction

- No lymph node or distant metastases, according to the following within the past 8
weeks:

- History/physical examination, including a detailed description of the location,
size, and stage of the sarcoma

- MRI with contrast of the primary tumor

- The maximum dimension of the primary tumor is measured in MRI images

- CT scan of the chest

- Multiple pulmonary nodules < 8 mm without a histological diagnosis detected
incidentally on a non-screening CT scan may be allowed

- CT scan with contrast of the abdomen and pelvis in patients with intermediate-
or high-grade sarcoma of the upper thigh

- No recurrent tumor after prior potentially curative therapy

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-1

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed)

- Bilirubin ≤ 1.5 mg/dL*

- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2 times upper
limit of normal*

- Serum creatinine ≤ 1.6 mg/dL OR creatinine clearance ≥ 55 mL/min*

- Left ventricular ejection fraction (LVEF) ≥ 50% by multiple gated acquisition scan
(MUGA) or echocardiogram*

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other invasive malignancy within the past 3 years, except nonmelanomatous skin
cancer or carcinoma in situ of the breast, oral cavity, or cervix

- No severe, active co-morbidity, including any of the following*:

- Unstable angina and/or congestive heart failure requiring hospitalization within
the past 6 months

- Transmural myocardial infarction within the past 6 months

- Acute bacterial infection or fungal infection requiring intravenous antibiotics

- Acquired Immune Deficiency Syndrome (AIDS) or immunocompromised patients

- HIV testing not required

- No NCI CTCAE v 3.0 grade 3-4 electrolyte abnormalities, including any of the
following*:

- Calcium < 7 mg/dL or > 12.5 mg/dL

- Glucose < 40 mg/dL or > 250 mg/dL

- Magnesium < 0.9 mg/dL or > 3 mg/dL

- Potassium < 3mmol/L or > 6 mmol/L

- Sodium < 130 mmol/L or > 155 mmol/L NOTE: *Applies to group 1 only, which was
closed to accrual as of 01/08/10)

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior excisional biopsy in which the majority of the tumor (≥ 50%) is removed

- No prior radiotherapy to the region of the study cancer that would result in overlap
of radiotherapy fields

- No other concurrent investigational agents