Surgery With or Without Combination Chemotherapy in Treating Patients With Lung Metastases From Soft Tissue Sarcoma
|ClinicalTrials.gov Identifier: NCT00002764|
Recruitment Status : Completed
First Posted : April 22, 2004
Last Update Posted : July 11, 2012
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether surgery plus combination chemotherapy is more effective than surgery alone in treating patients with lung metastases from soft tissue sarcoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of surgery plus combination chemotherapy with that of surgery alone in treating patients who have soft tissue sarcoma that has spread to the lung.
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer Kidney Cancer Metastatic Cancer Ovarian Cancer Pheochromocytoma Sarcoma||Biological: filgrastim Drug: doxorubicin hydrochloride Drug: ifosfamide Procedure: conventional surgery||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||340 participants|
|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)|
|Study Start Date :||April 1996|
|Primary Completion Date :||November 2000|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002764
|Lund University Hospital|
|Lund, Sweden, SE-22185|
|Study Chair:||A.N. Van Geel, MD||Daniel Den Hoed Cancer Center at Erasmus Medical Center|
|Study Chair:||Ronald H. Blum, MD||New York University School of Medicine|
|Study Chair:||Thor A. Alvegard, MD, PhD||Lund University Hospital|
|Study Chair:||Laurence H. Baker, DO, FACOI||University of Michigan Cancer Center|