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

This study has been completed.
Sponsor:
Collaborators:
Eastern Cooperative Oncology Group
Scandinavian Sarcoma Group
Southwest Oncology Group
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00002764
First received: November 1, 1999
Last updated: July 10, 2012
Last verified: July 2012
  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
Biological: filgrastim
Drug: doxorubicin hydrochloride
Drug: ifosfamide
Procedure: conventional surgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Estimated Enrollment: 340
Study Start Date: April 1996
Primary Completion Date: November 2000 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002764

Locations
Sweden
Lund University Hospital
Lund, Sweden, SE-22185
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Eastern Cooperative Oncology Group
Scandinavian Sarcoma Group
Southwest Oncology Group
Investigators
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

Additional Information:
No publications provided

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00002764     History of Changes
Other Study ID Numbers: EORTC-62933, EORTC-62933, E-EORTC-62933, SSG-EORTC-62933, SWOG-EORTC-62933
Study First Received: November 1, 1999
Last Updated: July 10, 2012
Health Authority: United States: Federal Government

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
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

Additional relevant MeSH terms:
Endometrial Neoplasms
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Ovarian Neoplasms
Pheochromocytoma
Lung Neoplasms
Sarcoma
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Kidney Diseases
Urologic Diseases
Neoplastic Processes
Pathologic Processes
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on April 23, 2014