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
- Determine local progression-free survival of patients with high-risk soft tissue
sarcoma treated with neoadjuvant etoposide, ifosfamide, and doxorubicin with or without
- 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
- 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
Local progression-free survival
Rolf D. Issels, MD, PhD
Klinikum der Universitaet Muenchen - Grosshadern Campus
United States: Federal Government