Surgery With or Without Combination Chemotherapy in Treating Patients With Lung Metastases From Soft Tissue Sarcoma

Ovarian Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002764
• Other study ID #: EORTC-62933
• Secondary ID: EORTC-62933E-EOR
• Status: Completed
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: July 10, 2012
• Start date: April 1996

Study information

• Verified date: July 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 340
• Est. primary completion date: November 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometrial Cancer
• Kidney Cancer
• Metastatic Cancer
• Neoplasm Metastasis
• Ovarian Cancer
• Pheochromocytoma
• Sarcoma

Intervention

Biological:
• filgrastim

Drug:
• doxorubicin hydrochloride

• ifosfamide

Procedure:
• conventional surgery

Locations

Country	Name	City	State
Sweden	Lund University Hospital	Lund

Sponsors (4)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC	Eastern Cooperative Oncology Group, Scandinavian Sarcoma Group, Southwest Oncology Group

Country where clinical trial is conducted

Sweden,