Combination Chemotherapy With or Without Hyperthermia Therapy in Treating Patients With Soft Tissue Sarcoma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2006 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Collaborator:
The European Society for Hyperthermic Oncology
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003052
First received: November 1, 1999
Last updated: May 7, 2010
Last verified: November 2006
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Purpose
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 |
|---|---|---|
|
Sarcoma |
Drug: doxorubicin hydrochloride Drug: etoposide Drug: ifosfamide Procedure: conventional surgery Procedure: hyperthermia treatment Radiation: radiation therapy |
Phase 3 |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Drug Information available for:
Ifosfamide
Doxorubicin
Doxorubicin hydrochloride
Etoposide
Etoposide phosphate
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Local progression-free survival [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 340 |
| Study Start Date: | July 1997 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003052
Locations
| 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 | |
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
The European Society for Hyperthermic Oncology
Investigators
| 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 |
More Information
Additional Information:
Publications:
Issels RD, Lindner LH, Wust P, et al.: Regional hyperthermia (RHT) improves response and survival when combined with systemic chemotherapy in the management of locally advanced, high grade soft tissue sarcomas (STS) of the extremities, the body wall and the abdomen: a phase III randomised pros. [Abstract] J Clin Oncol 25 (Suppl 18): A-10009, 547s, 2007.
Lindner LH, Schlemmer M, Hohenberger P, et al.: Risk assessment of early progression among 213 pts with high-risk soft tissue sarcomas (HR-STS) treated with neoadjuvant chemotherapy regional hyperthermia: EORTC 62961/ESHO-RHT 95 intergroup phase III study. [Abstract] J Clin Oncol 23 (Suppl 16): A-9020, 821s, 2005.
| ClinicalTrials.gov Identifier: | NCT00003052 History of Changes |
| Other Study ID Numbers: | CDR0000065699, EORTC-62961 |
| Study First Received: | November 1, 1999 |
| Last Updated: | May 7, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Fever Sarcoma Body Temperature Changes Signs and Symptoms Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Doxorubicin Etoposide phosphate Isophosphamide mustard |
Etoposide Ifosfamide Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 22, 2013