Clinical trial NCT00589121 (phase 2, status: completed)
Conditions: lymphedema, musculoskeletal complications, radiation fibrosis, radiation toxicity, sarcoma
ICD codes: Q82.0, I97.2, I89.0, M96.89, K62.7, G62.82, N46.024, N46.124, T66.XXXS, Z57.1, N52.35, K62.7, G62.82, N46.024, N46.124, T66.XXXS, Z57.1, N52.35, C96.A, C46.9, C96.22, C46.0, C46.2, C92.31, C92.32
Drugs: chemotherapy
SMILES: [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC
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