Image-Guided Radiation Therapy in Treating Patients With Primary Soft Tissue Sarcoma of the Shoulder, Arm, Hip, or Leg
Condition: Lymphedema; Musculoskeletal Complications; Radiation Fibrosis; Radiation Toxicity; Sarcoma
MeSH terms: Sarcoma; Lymphedema; Fibrosis; Radiation Fibrosis Syndrome
Intervention: Chemotherapy; Radiation therapy; Surgery
Intervention description: Up to 6 courses of investigator's choice of neoadjuvant, adjuvant, concurrent, or interdigitated chemotherapy; Preoperative IGRT (3D-CRT or IMRT): If receiving neoadjuvant or adjuvant chemotherapy or no chemotherapy: 50 Gy (2 Gy once a day, 5 times a week). If receiving concurrent or interdigitated chemotherapy: 44 Gy (2 Gy once a day, 5 times a week). Postoperative radiotherapy boost for patients with positive margins following surgery: 16 Gy (2 Gy once a day, 5 times a week) external beam radiation therapy or 16 Gy at ≤ 80 cGy per hour brachytherapy or 3.4 Gy/fraction in 4 fractions brachytherapy or 10-12.5 Gy in a single fraction intraoperative radiation therapy boost.; Resection of the sarcoma with the goal of having negative pathologic margins. Every effort should be made to have limb preservation surgery unless there is documented evidence of tumor progression that would require amputation for an appropriate negative margin resection. All lesions of the extremities should be treated with wide excision.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 98.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: radiation fibrosis; radiation toxicity; lymphedema; musculoskeletal complications; stage I adult soft tissue sarcoma; stage II adult soft tissue sarcoma; adult extraskeletal chondrosarcoma; stage III adult soft tissue sarcoma

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.
    

Eligibility 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