Combination Chemotherapy With or Without Hyperthermia Therapy in Treating Patients With Soft Tissue Sarcoma
Condition: Sarcoma
MeSH terms: Sarcoma; Hyperthermia
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Hyperthermia therapy kills tumor cells by heating them to several
      degrees above body temperature. It is not known whether receiving chemotherapy plus
      hyperthermia is more effective than receiving chemotherapy alone in treating patients with
      soft tissue sarcoma.

      PURPOSE: This randomized phase III trial is studying combination chemotherapy alone to see
      how well it works compared to combination chemotherapy and hyperthermia therapy in treating
      patients with soft tissue sarcoma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine local progression-free survival of patients with high-risk soft tissue sarcoma
           treated with neoadjuvant etoposide, ifosfamide, and doxorubicin with or without regional
           hyperthermia.

        -  Determine the tumor response rate, local disease control rate, and overall survival in
           patients treated with this regimen.

      OUTLINE: This is a randomized study. Patients are stratified according to high-risk category
      (S1 vs S2 vs S3) and disease site (extremity vs nonextremity). Patients are randomized to one
      of two treatment arms.

        -  Arm I: Patients receive etoposide IV over 30 minutes on days 1 and 4, ifosfamide IV over
           60 minutes on days 1-4, and doxorubicin IV over 30 minutes on day 1. Treatment continues
           every 21 days for a total of 4 courses. Patients also undergo regional hyperthermia.

        -  Arm II: Patients receive chemotherapy alone as in arm I. Patients in both arms undergo
           definitive surgery 4-6 weeks after chemotherapy. Patients also undergo radiotherapy
           beginning 4-6 weeks after surgery. After completion of surgery and radiotherapy,
           patients with non-resectable tumors showing no disease progression receive an additional
           4 courses of chemotherapy with or without regional hyperthermia according to above
           treatment schedule.

      Patients are followed every 3 months for 1 year, every 4 months for 2 years, and then every 6
      months thereafter.

      PROJECTED ACCRUAL: A total of 340 patients (170 patients per arm) will be accrued for this
      study within 3.5 years.
    

Intervention name(s): doxorubicin hydrochloride; etoposide; ifosfamide; conventional surgery; hyperthermia treatment; radiation therapy
Intervention type(s): Drug; Drug; Drug; Procedure; Procedure; Radiation
Intervention MeSH terms: Doxorubicin; Liposomal doxorubicin; Etoposide; Ifosfamide
Allocation: Randomized
Primary purpose: Treatment
Keywords: adult angiosarcoma; adult fibrosarcoma; adult leiomyosarcoma; adult liposarcoma; adult neurofibrosarcoma; adult synovial sarcoma; stage III adult soft tissue sarcoma; recurrent adult soft tissue sarcoma; adult extraskeletal osteosarcoma; adult malignant fibrous histiocytoma; adult rhabdomyosarcoma; stage I adult soft tissue sarcoma; stage II adult soft tissue sarcoma