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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003052
First Posted: January 27, 2003
Last Update Posted: September 17, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The European Society for Hyperthermic Oncology
Information provided by:
National Cancer Institute (NCI)
  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:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Local progression-free survival

Secondary Outcome Measures:
  • Response as assessed by WHO criteria
  • Overall survival
  • Relapse-free survival
  • Acute and late complications as assessed by CTC v 1.0

Estimated Enrollment: 340
Study Start Date: July 1997
Study Completion Date: June 2010
Detailed Description:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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


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
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
  More 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00003052     History of Changes
Other Study ID Numbers: CDR0000065699
EORTC-62961
First Submitted: November 1, 1999
First Posted: January 27, 2003
Last Update Posted: September 17, 2013
Last Verified: November 2006

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:
Sarcoma
Fever
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Body Temperature Changes
Signs and Symptoms
Doxorubicin
Liposomal doxorubicin
Etoposide
Etoposide phosphate
Isophosphamide mustard
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