METASTASECTOMY AND CHEMOTHERAPY FOR LUNG METASTASES FROM SOFT TISSUE SARCOMA: A RANDOMIZED PHASE III STUDY (AN INTERGROUP STUDY WITH THE SCANDINAVIAN SARCOMA GROUP)
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.
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.
PROJECTED ACCRUAL: A total of 340 patients (170 per treatment arm) will be accrued for this
study within approximately 4.5 years.
Allocation: Randomized, Primary Purpose: Treatment
A.N. Van Geel, MD
Daniel Den Hoed Cancer Center at Erasmus Medical Center
United States: Federal Government