Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Surgery With or Without Combination Chemotherapy in Treating Patients With Lung Metastases From Soft Tissue Sarcoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	16 and over		EORTC-62933 E-EORTC-62933, SSG-EORTC-62933, SWOG-EORTC-62933, NCT00002764

Objectives

I. Compare disease control, overall survival, and relapse-free survival in 
patients with lung metastases secondary to soft tissue sarcoma treated with 
high-dose doxorubicin and ifosfamide with or without filgrastim (G-CSF) before 
and after metastasectomy vs metastasectomy alone.

II. Determine the safety and morbidity of this regimen in these patients.

Entry Criteria

Disease Characteristics:

Histologically proven soft tissue sarcoma with pulmonary metastases for which
radical metastasectomy is feasible

Eligible subtypes:
 Malignant fibrous histiocytoma          Liposarcoma
 Synovial sarcoma                        Malignant paraganglioma
 Fibrosarcoma                            Leiomyosarcoma
 Neurogenic sarcoma                      Unclassified sarcoma
 Angiosarcoma (including hemangiopericytoma)
 Miscellaneous sarcoma (including mixed mesodermal tumors of the uterus)

Ineligible subtypes:
 Alveolar rhabdomyosarcoma               Kaposi's sarcoma
 Rhabdomyosarcoma of any type            Malignant mesothelioma
 Chondrosarcoma                          Neuroblastoma
 Dermatofibrosarcoma                     Osteosarcoma
 Epithelioid sarcoma                     Primitive neuroectodermal tumor
 Ewing's sarcoma

No extrapulmonary disease

Previously treated local recurrence allowed 

Patients with primarily metastatic disease must have undergone radical
treatment of primary tumor according to local protocols 
 Reevaluation of metastases required before randomization

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified

Chemotherapy:
 No prior chemotherapy for metastatic disease
 Prior neoadjuvant or adjuvant chemotherapy for primary soft tissue sarcoma
  allowed if cumulative dose of doxorubicin no greater than 200 mg/m2
 At least 1 year since prior chemotherapy
 
Endocrine therapy:
 Not specified

Radiotherapy:
 Not specified

Surgery:
 See Disease Characteristics

Patient Characteristics:

Age:
 16 and over

Performance status:
 WHO 0-1

Life expectancy:
 Not specified

Hematopoietic:
 WBC at least 3,000/mm3
 Platelet count at least 120,000/mm3

Hepatic:
 Bilirubin no greater than 1.25 times normal

Renal:
 Creatinine no greater than 1.6 mg/dL OR
 Creatinine clearance at least 60 mL/min

Cardiovascular:
 No history of cardiovascular disease

Other:
 No other severe medical illness (including psychosis)
 No prior or concurrent other primary malignancy except adequately treated
  carcinoma in situ of the cervix or basal cell carcinoma

Expected Enrollment

A total of 340 patients (170 per treatment arm) will be accrued for this study 
within approximately 4.5 years.

Outline

This is a randomized, multicenter study. Patients are stratified according to 
location of metastases (unilateral vs bilateral). Patients are randomized to 1 
of 2 treatment arms.

Arm I: Patients are assigned to regimen A or B.
 Regimen A: Patients receive high-dose doxorubicin IV and ifosfamide IV
  continuously on day 1 and filgrastim (G-CSF) subcutaneously on days 3-13. 
 Regimen B: Patients receive chemotherapy as above without G-CSF.
Treatment on both regimens continues every 3 weeks for 3 courses. Patients 
then undergo radical pulmonary metastasectomy via thoracotomy or sternotomy 
with wedge resection or lobectomy. Patients with responding disease after 
metastasectomy receive 2 additional courses on the regimen to which they were 
originally assigned.

Arm II: Patients undergo radical pulmonary metastasectomy as in arm I.     

Patients are followed every 3 months for 2 years, every 6 months for 2 years, 
and then annually thereafter.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

A.N. Van Geel, MD, Protocol chair		Ph: 31-10-4391793 Email: geel@chiha3r.nl

Eastern Cooperative Oncology Group

Ronald Blum, MD, Protocol chair		Ph: 212-263-6485

Scandinavian Sarcoma Group

Thor Alvegard, MD, PhD, Protocol chair		Ph: 46-46-177-550 Email: thor.alvegard@cancerepid.lu.se

Southwest Oncology Group

Laurence Baker, DO, FACOI, Protocol chair		Ph: 734-647-4565; 800-865-1125 Email: bakerl@umich.edu

Registry Information
Official Title		METASTASECTOMY AND CHEMOTHERAPY FOR LUNG METASTASES FROM SOFT TISSUE SARCOMA: A RANDOMIZED PHASE III STUDY (AN INTERGROUP STUDY WITH THE SCANDINAVIAN SARCOMA GROUP)
Trial Start Date		1996-04-15
Registered in ClinicalTrials.gov		NCT00002764
Date Submitted to PDQ		1996-04-15
Information Last Verified		2007-05-08
NCI Grant/Contract Number		U10-CA21115

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