Skip to main content
OpenTrials
Completed

NCT Number: NCT00002764

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Endometrial Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Neoplasms Endometrial Stromal Tumors Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fibrosarcoma Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Hemangiopericytoma, Malignant Hemangiosarcoma Histiocytoma Histiocytoma, Malignant Fibrous Kidney Cancer Kidney Diseases Kidney Neoplasms Leiomyosarcoma Liposarcoma Male Urogenital Diseases Malignant mesenchymal tumor Metastatic Cancer Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Adipose Tissue Neoplasms, Complex and Mixed Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibrous Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Muscle Tissue Neoplasms, Nerve Tissue Neoplasms, Vascular Tissue Neoplastic Processes Nerve Sheath Neoplasms Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Neuroendocrine Tumors Neurofibroma Neurofibrosarcoma Neuromuscular Diseases Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Paraganglioma Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Peripheral Nervous System Neoplasms Pheochromocytoma Sarcoma Sarcoma, Endometrial Stromal Sarcoma, Synovial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Diseases Uterine Neoplasms

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Lund University Hospital

Lund, SE-22185, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

filgrastim

Biological

Doxorubicin hydrochloride

Drug

ifosfamide

Drug

conventional surgery

Procedure

Sponsors and collaborators

Lead sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Network

Collaborators

  • Eastern Cooperative Oncology Group
  • SWOG Cancer Research Network
  • Scandinavian Sarcoma Group

Registry information

Official study title

METASTASECTOMY AND CHEMOTHERAPY FOR LUNG METASTASES FROM SOFT TISSUE SARCOMA: A RANDOMIZED PHASE III STUDY (AN INTERGROUP STUDY WITH THE SCANDINAVIAN SARCOMA GROUP)

Important dates

Study start
1996
Primary completion
2000
First posted
Apr 22, 2004
Registry last updated
Jul 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.