Clinical trial NCT00003052 (phase 3, status: completed)
Conditions: sarcoma
ICD codes: C96.A, C46.9, C96.22, C46.0, C46.2, C92.31, C92.32
Drugs: doxorubicin hydrochloride, etoposide, ifosfamide
SMILES: COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O, OCCOCCN1CCN(CC1)C(C1=CC=CC=C1)C1=CC=C(Cl)C=C1, N[C@@H](CCCNC(N)=N)C(O)=O
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically proven grade II or III soft tissue sarcoma of one of following
             high-risk groups:

               -  Grade II/III primary tumor with lesion size of at least 5 cm, deep, and
                  extracompartmental (S1)

               -  Local recurrence of primary tumor (S2)

               -  Inadequate surgical excision of S1 or S2 (S3)

          -  Disease recurrence after prior surgery allowed

          -  The following histological types are eligible:

               -  Malignant fibrous histiocytoma

               -  Liposarcoma (round cell and pleomorphic)

               -  Leiomyosarcoma

               -  Fibrosarcoma

               -  Rhabdomyosarcoma

               -  Synovial sarcoma

               -  Malignant paraganglioma

               -  Neurofibrosarcoma (malignant schwannoma)

               -  Extraskeletal Ewing's sarcoma

               -  Extraskeletal osteosarcoma

               -  Malignant peripheral neuroectodermal tumors

               -  Mesenchymal chondrosarcoma

               -  Angiosarcoma

               -  Miscellaneous sarcoma

               -  Unclassified sarcoma

          -  No distant metastases

        PATIENT CHARACTERISTICS:

        Age:

          -  18 to 70

        Performance status:

          -  WHO 0-2 OR

          -  Karnofsky 60-100%

        Life expectancy:

          -  Not specified

        Hematopoietic:

          -  WBC at least 3,500/mm^3

          -  Platelet count at least 100,000/mm^3

          -  No bleeding disorder

        Hepatic:

          -  Bilirubin less than 1.25 times upper limit of normal

          -  No severe hepatic dysfunction

        Renal:

          -  Creatinine clearance greater than 60 mL/min

          -  No chronic renal failure

        Cardiovascular:

          -  No documented existing cardiac failure

          -  No manifest heart failure (New York Heart Association class III or IV)

          -  Left ventricular ejection fraction no more than 10% below institutional normal

        Other:

          -  No other prior or concurrent malignancy except adequately treated basal cell skin
             cancer or carcinoma in situ of the cervix

          -  No other severe disease

          -  No severe cerebrovascular disease

          -  No extremely obese patients

          -  No prior metallic implants relevant to the regional hyperthermia field

          -  Not pregnant or nursing

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  Not specified

        Chemotherapy:

          -  No prior chemotherapy

        Endocrine therapy:

          -  Not specified

        Radiotherapy:

          -  No prior radiotherapy (except to disease recurrence outside study irradiation field)

        Surgery:

          -  See Disease Characteristics

          -  No prior mutilative surgery