METASTASECTOMY AND CHEMOTHERAPY FOR LUNG METASTASES FROM SOFT TISSUE SARCOMA: A RANDOMIZED PHASE III STUDY (AN INTERGROUP STUDY WITH THE SCANDINAVIAN SARCOMA GROUP)
16 Years
N/A
Both
Endometrial Cancer, Kidney Cancer, Metastatic Cancer, Ovarian Cancer, Pheochromocytoma, Sarcoma
Trial Information
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.
Inclusion 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
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
A.N. Van Geel, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Daniel Den Hoed Cancer Center at Erasmus Medical Center
Authority:
United States: Federal Government
Study ID:
EORTC-62933
NCT ID:
NCT00002764
Start Date:
April 1996
Completion Date:
Related Keywords:
- Endometrial Cancer
- Kidney Cancer
- Metastatic Cancer
- Ovarian Cancer
- Pheochromocytoma
- Sarcoma
- adult angiosarcoma
- adult fibrosarcoma
- adult leiomyosarcoma
- adult liposarcoma
- adult neurofibrosarcoma
- adult synovial sarcoma
- recurrent adult soft tissue sarcoma
- adult malignant fibrous histiocytoma
- adult malignant hemangiopericytoma
- adult malignant mesenchymoma
- localized benign pheochromocytoma
- regional pheochromocytoma
- lung metastases
- stage IV uterine sarcoma
- recurrent uterine sarcoma
- uterine leiomyosarcoma
- endometrial stromal sarcoma
- ovarian sarcoma
- clear cell sarcoma of the kidney
- stage IV adult soft tissue sarcoma
- Endometrial Neoplasms
- Carcinoma, Renal Cell
- Kidney Neoplasms
- Neoplasm Metastasis
- Neoplasms
- Neoplasms, Second Primary
- Ovarian Neoplasms
- Pheochromocytoma
- Lung Neoplasms
- Adenoma
- Sarcoma
Name | Location |
|---|
