Combination Chemotherapy With or Without Hyperthermia Therapy in Treating Patients With Soft Tissue Sarcoma
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ClinicalTrials.gov Identifier: NCT00003052 |
Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : September 17, 2013
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Sarcoma | Drug: doxorubicin hydrochloride Drug: etoposide Drug: ifosfamide Procedure: conventional surgery Procedure: hyperthermia treatment Radiation: radiation therapy | Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 340 participants |
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 |
Study Start Date : | July 1997 |
Actual Study Completion Date : | June 2010 |

- Local progression-free survival
- Response as assessed by WHO criteria
- Overall survival
- Relapse-free survival
- Acute and late complications as assessed by CTC v 1.0

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
-
Histologically proven grade II or III soft tissue sarcoma of one of following high-risk groups:
- Grade II/III primary tumor with lesion size of at least 5 cm, deep, and extracompartmental (S1)
- Local recurrence of primary tumor (S2)
- Inadequate surgical excision of S1 or S2 (S3)
- Disease recurrence after prior surgery allowed
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The following histological types are eligible:
- Malignant fibrous histiocytoma
- Liposarcoma (round cell and pleomorphic)
- Leiomyosarcoma
- Fibrosarcoma
- Rhabdomyosarcoma
- Synovial sarcoma
- Malignant paraganglioma
- Neurofibrosarcoma (malignant schwannoma)
- Extraskeletal Ewing's sarcoma
- Extraskeletal osteosarcoma
- Malignant peripheral neuroectodermal tumors
- Mesenchymal chondrosarcoma
- Angiosarcoma
- Miscellaneous sarcoma
- Unclassified sarcoma
- No distant metastases
PATIENT CHARACTERISTICS:
Age:
- 18 to 70
Performance status:
- WHO 0-2 OR
- Karnofsky 60-100%
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,500/mm^3
- Platelet count at least 100,000/mm^3
- No bleeding disorder
Hepatic:
- Bilirubin less than 1.25 times upper limit of normal
- No severe hepatic dysfunction
Renal:
- Creatinine clearance greater than 60 mL/min
- No chronic renal failure
Cardiovascular:
- No documented existing cardiac failure
- No manifest heart failure (New York Heart Association class III or IV)
- Left ventricular ejection fraction no more than 10% below institutional normal
Other:
- No other prior or concurrent malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix
- No other severe disease
- No severe cerebrovascular disease
- No extremely obese patients
- No prior metallic implants relevant to the regional hyperthermia field
- Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy (except to disease recurrence outside study irradiation field)
Surgery:
- See Disease Characteristics
- No prior mutilative surgery

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003052
Germany | |
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 | |
Klinikum der Universitaet Muenchen - Grosshadern Campus | |
Munich, Germany, D-81377 |
OverallOfficial: | Rolf D. Issels, MD, PhD | Klinikum der Universitaet Muenchen - Grosshadern Campus | |
Study Chair: | Rolf D. Issels, MD, PhD | Klinikum der Universitaet Muenchen - Grosshadern Campus |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00003052 |
Other Study ID Numbers: |
CDR0000065699 EORTC-62961 |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | September 17, 2013 |
Last Verified: | November 2006 |
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 |
Sarcoma Fever Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Body Temperature Changes Doxorubicin Liposomal doxorubicin Etoposide Ifosfamide |
Antibiotics, Antineoplastic Antineoplastic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic Antineoplastic Agents, Alkylating Alkylating Agents |