- To determine the effect of reduced radiation volume using image-guided radiotherapy (IGRT) on lymphedema ≥ grade 2, subcutaneous fibrosis, and joint stiffness at 2 years in patients with primary soft tissue sarcoma of the extremity.
- To estimate the rates of other grade 3-5 adverse events as measured by CTCAE v3.0.
- To determine the pattern of first failure, including local failure (in-field, marginal, and outside-field failure), regional failure, distant failure, and death without disease progression.
- To estimate the rates of local failure, local-regional failure, distant failure, distant disease-free survival, disease-free survival, overall survival, and second primary tumor.
- To estimate the rate of wound complications.
- To correlate the degree of late radiation morbidity (defined as any lymphedema, subcutaneous fibrosis, or joint stiffness) at 2 years with scores on the clinical measure, Musculoskeletal Tumor Rating Scale (MTRS).
OUTLINE: This is a multicenter study.
- Neoadjuvant radiotherapy: Patients are assigned to 1 of 2 treatment groups (group 1 closed to accrual as of 01/08/10).
- Group 1 (closed to accrual as of 01/08/10): Patients undergo 3-D conformal radiotherapy (3D-CRT) or intensity-modulated therapy (IMRT) once daily, 5 days a week, for 4½-5 weeks. Patients also receive up to 6 courses of neoadjuvant, adjuvant, concurrent, or interdigitated chemotherapy.
- Group 2: Patients undergo 3D-CRT or IMRT once daily, 5 days a week, for 5 weeks.
- Surgery: At 4-8 weeks after completion of neoadjuvant radiotherapy, patients undergo surgical resection of the tumor. Patients with positive tumor margins (residual tumor) undergo intraoperative radiotherapy boost or proceed to adjuvant radiotherapy within 2 weeks after surgery.
- Adjuvant radiotherapy: Patients undergo either external-beam radiotherapy (EBRT) once daily for 8 fractions or brachytherapy.
After completion of study treatment, patients are followed at least every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
- 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:
- Extraosseous primitive neuroectodermal tumor (PNET)
- Soft tissue Ewing sarcoma
- Kaposi sarcoma
- Aggressive fibromatosis (desmoid tumor)
- Dermatofibrosarcoma protuberans
- 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
- 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*
- AST or ALT ≤ 2 times upper limit of normal*
- Serum creatinine ≤ 1.6 mg/dL OR creatinine clearance ≥ 55 mL/min*
- LVEF ≥ 50% by 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
Last updated: 12/13/2011
NCT ID: NCT00589121