|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
European Organization for Research and Treatment of Cancer Eastern Cooperative Oncology Group Scandinavian Sarcoma Group Southwest Oncology Group |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002764 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Endometrial Cancer Kidney Cancer Metastatic Cancer Ovarian Cancer Pheochromocytoma Sarcoma |
Drug: doxorubicin hydrochloride Drug: filgrastim Drug: ifosfamide Procedure: conventional surgery |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| 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) |
| Estimated Enrollment: | 340 |
| Study Start Date: | April 1996 |
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.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Sweden | |
| 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 |
More Information
| Study ID Numbers: | CDR0000064721, EORTC-62933, E-EORTC-62933, SSG-EORTC-62933, SWOG-EORTC-62933 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00002764 |
| Health Authority: | United States: Federal Government |
|
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 |
|
Sarcoma, Endometrial Stromal Fibrosarcoma Histiocytoma, Benign Fibrous Malignant mesenchymal tumor Urogenital Neoplasms Urologic Neoplasms Sarcoma, Synovial Neoplasms, Connective and Soft Tissue Endometrial Neoplasms Neoplasm Metastasis Neuroepithelioma Kidney Diseases Endocrine Gland Neoplasms Endometrial stromal sarcoma Synovial sarcoma |
Genital Neoplasms, Female Sarcoma, Clear Cell Endocrine System Diseases Renal cancer Hemangiopericytoma Doxorubicin Carcinoma Neuroectodermal Tumors Liposarcoma Histiocytoma Sarcoma Uterine sarcoma Neoplasms, Glandular and Epithelial Histiocytoma, Malignant Fibrous Leiomyosarcoma |
|
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Antibiotics, Antineoplastic Pharmacologic Actions Adnexal Diseases |
Neoplasms Neoplastic Processes Neoplasms by Site Pathologic Processes Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents |
