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Sponsors and Collaborators: |
European Organization for Research and Treatment of Cancer European Society For Hypothermic Oncology |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003052 |
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.
Condition | Intervention | Phase |
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Sarcoma |
Drug: doxorubicin hydrochloride Drug: etoposide Drug: ifosfamide Procedure: conventional surgery Procedure: hyperthermia treatment Procedure: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
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 |
Estimated Enrollment: | 340 |
Study Start Date: | July 1997 |
OBJECTIVES:
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.
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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven grade II or III soft tissue sarcoma of one of following high-risk groups:
The following histological types are eligible:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Germany | |
Klinikum der Universitaet Muenchen - Grosshadern Campus | |
Munich, Germany, D-81377 | |
Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch | |
Berlin, Germany, D-13122 | |
Universitaetsklinikum Essen | |
Essen, Germany, D-45122 | |
Universitaetsklinikum Hamburg-Eppendorf | |
Hamburg, Germany, D-20246 |
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 |
Study ID Numbers: | CDR0000065699, EORTC-62961 |
Study First Received: | November 1, 1999 |
Last Updated: | May 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003052 |
Health Authority: | United States: Federal Government |
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 |
Fibrosarcoma Histiocytoma, Malignant Fibrous Histiocytoma, Benign Fibrous Leiomyosarcoma Malignant mesenchymal tumor Osteogenic sarcoma Etoposide phosphate Soft tissue sarcomas Fever Sarcoma, Synovial Neoplasms, Connective and Soft Tissue Etoposide Rhabdomyosarcoma |
Synovial sarcoma Osteosarcoma Hemangiosarcoma Recurrence Doxorubicin Liposarcoma Ifosfamide Histiocytoma Mechlorethamine Sarcoma Malignant fibrous histiocytoma Isophosphamide mustard |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Antineoplastic Agents, Alkylating Antibiotics, Antineoplastic Alkylating Agents Antineoplastic Agents, Phytogenic Pharmacologic Actions |