Combination Chemotherapy With or Without Hyperthermia Therapy in Treating Patients With Soft Tissue Sarcoma

This study has been completed.
Sponsor:
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: September 16, 2013
Last verified: November 2006

November 1, 1999
September 16, 2013
July 1997
Not Provided
Local progression-free survival [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00003052 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
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Combination Chemotherapy With or Without Hyperthermia Therapy in Treating Patients With Soft Tissue Sarcoma
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Treatment
Sarcoma
  • Drug: doxorubicin hydrochloride
  • Drug: etoposide
  • Drug: ifosfamide
  • Procedure: conventional surgery
  • Procedure: hyperthermia treatment
  • Radiation: radiation therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
340
June 2010
Not Provided

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00003052
CDR0000065699, EORTC-62961
Not Provided
Not Provided
European Organisation for Research and Treatment of Cancer - EORTC
The European Society for Hyperthermic Oncology
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
National Cancer Institute (NCI)
November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP