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Surgery With or Without Combination Chemotherapy in Treating Patients With Lung Metastases From Soft Tissue Sarcoma Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Surgery With or Without Combination Chemotherapy in Treating Patients With Lung Metastases From Soft Tissue Sarcoma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Surgery With or Without Combination Chemotherapy in Treating Patients With Lung Metastases From Soft Tissue Sarcoma Clinical research trials and Surgery With or Without Combination Chemotherapy in Treating Patients With Lung Metastases From Soft Tissue Sarcoma medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Surgery With or Without Combination Chemotherapy in Treating Patients With Lung Metastases From Soft Tissue Sarcoma. Surgery With or Without Combination Chemotherapy in Treating Patients With Lung Metastases From Soft Tissue Sarcoma Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Surgery With or Without Combination Chemotherapy in Treating Patients With Lung Metastases From Soft Tissue Sarcoma clinical trial. Participants oftentimes recieve the finest healthcare available for their Surgery With or Without Combination Chemotherapy in Treating Patients With Lung Metastases From Soft Tissue Sarcoma condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Surgery With or Without Combination Chemotherapy in Treating Patients With Lung Metastases From Soft Tissue Sarcoma  Surgery With or Without Combination Chemotherapy in Treating Patients With Lung Metastases From Soft Tissue Sarcoma
Surgery With or Without Combination Chemotherapy in Treating Patients With Lung Metastases From Soft Tissue Sarcoma
For Condition: adult soft tissue sarcoma,ovarian sarcoma,kidney tumor,uterine sarcoma
Status: No longer recruiting
Sponsor(s): EORTC Soft Tissue and Bone Sarcoma Cooperative Group , Eastern Cooperative Oncology Group,Scandinavian Sarcoma Group,Southwest Oncology Group
Synopsis: 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.
Details: 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. PROTOCOL 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders:
Protocol Entry Criteria: PROTOCOL 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
OleNielsen, Study Chair, EORTC Soft Tissue and Bone Sarcoma Cooperative Group
Lund University Hospital
Lund, , SE-22185
Sweden
Additional Information:
Study ID Numbers: CDR0000064721; EORTC-62933
Study Start Date: April 1996
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002764
Other Kidney Tumor Studies:
1. Temozolomide and Thalidomide in Treating Patients With Metastatic, Locally Advanced, or Unresectable Leiomyosarcoma
2. Liposomal Doxorubicin and Carboplatin in Treating Patients With Gynecologic Cancer
3. Surgery With or Without Chemotherapy in Treating Patients With Soft Tissue Sarcoma
4. Surgery With or Without Combination Chemotherapy in Treating Patients With Lung Metastases From Soft Tissue Sarcoma
5. Exatecan Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma
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Surgery With or Without Combination Chemotherapy in Treating Patients With Lung Metastases From Soft Tissue Sarcoma
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