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

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Collaborator: The European Society for Hyperthermic Oncology
• Treatments: Doxorubicin; Etoposide; Etoposide phosphate; Ifosfamide; Isophosphamide mustard; Liposomal doxorubicin

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