Image-Guided Radiation Therapy in Treating Patients With Primary Soft Tissue Sarcoma of the Shoulder, Arm, Hip, or Leg

• Status: Completed
• Trial end date: 2018-05-21
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Image-guided radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a lower dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

PURPOSE: This phase II trial is studying the side effects and how well image-guided radiation therapy works in treating patients with primary soft tissue sarcoma of the shoulder, arm, hip, or leg.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radiation Therapy Oncology Group
• Collaborators: National Cancer Institute (NCI); NRG Oncology

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