Combination Chemotherapy With or Without Hyperthermia Therapy in Treating Patients With Soft Tissue Sarcoma
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.
Drug: doxorubicin hydrochloride
Procedure: conventional surgery
Procedure: hyperthermia treatment
Radiation: radiation therapy
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|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|
- Local progression-free survival [ Designated as safety issue: No ]
- Response as assessed by WHO criteria [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Relapse-free survival [ Designated as safety issue: No ]
- Acute and late complications as assessed by CTC v 1.0 [ Designated as safety issue: No ]
|Study Start Date:||July 1997|
|Study Completion Date:||June 2010|
- 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.
|Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch|
|Berlin, Germany, D-13122|
|Essen, Germany, D-45122|
|Hamburg, Germany, D-20246|
|Klinikum der Universitaet Muenchen - Grosshadern Campus|
|Munich, Germany, D-81377|
|Investigator:||Rolf D. Issels, MD, PhD||Klinikum der Universitaet Muenchen - Grosshadern Campus|
|Study Chair:||Rolf D. Issels, MD, PhD||Klinikum der Universitaet Muenchen - Grosshadern Campus|