Sarcoma Clinical Trial
Official title:
Randomized Study Comparing Neoadjuvant Chemotherapy Etoposide + Ifosfamide + Adriamycin (EIA) Combined With Regional Hyperthermia (RHT) Versus Neoadjuvant Chemotherapy Alone in the Treatment of High-Risk Soft Tissue Sarcomas in Adults
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.
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.
;
Allocation: Randomized, Primary Purpose: Treatment
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