Ifosfamide or Doxorubicin in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma
- Conditions
- Sarcoma
- Registration Number
- NCT00003212
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether ifosfamide or doxorubicin is more effective for advanced or metastatic soft tissue sarcoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of ifosfamide with that of doxorubicin in treating patients who have advanced or metastatic soft tissue sarcoma.
- Detailed Description
OBJECTIVES: I. Determine the progression free survival rate in patients with advanced or metastatic soft tissue sarcoma treated with either of two different regimens of ifosfamide or doxorubicin. II. Assess the toxic effects of these therapies and response rate in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized into one of 3 arms (continuous ifosfamide, ifosfamide daily for 3 days, or doxorubicin). Patients are stratified by performance status (0 vs 1), liver involvement (no vs yes), histological type (leiomyosarcoma vs synovial sarcoma vs other), and histological grade (1 vs 2 vs 3). Arm I: Patients receive doxorubicin by bolus infusion for 5-20 minutes once every 3 weeks. Arm II: Patients receive ifosfamide by intravenous infusion for 4 hours on days 1, 2, and 3 every three weeks. Arm III: Patients receive ifosfamide by intravenous infusion for 72 hours every 3 weeks. Patients are assessed after every 2 courses of therapy. Each course of therapy consists of 3 weeks of treatment. Patients may receive a maximum of 6 courses of therapy in the absence of toxicity and disease progression. Patients are followed every 12 weeks for survival.
PROJECTED ACCRUAL: A total of 780 patients (260 per treatment arm) will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 780
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (23)
Klinikum Grosshadern
🇩🇪Munich, Germany
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
🇵🇱Warsaw, Poland
Hospital Insular de Gran Canaria
🇪🇸Las Palmas, Spain
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium
Institut Gustave Roussy
🇫🇷Villejuif, France
Rotterdam Cancer Institute
🇳🇱Rotterdam, Netherlands
Aarhus Kommunehospital
🇩🇰Aarhus, Denmark
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
Rigshospitalet
🇩🇰Copenhagen, Denmark
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
National Cancer Institute - Bratislava
🇸🇰Bratislava, Slovakia
Centre Leon Berard
🇫🇷Lyon, France
National Institute of Oncology
🇭🇺Budapest, Hungary
Royal Marsden NHS Trust
🇬🇧London, England, United Kingdom
Weston Park Hospital
🇬🇧Sheffield, England, United Kingdom
Antoni van Leeuwenhoekhuis
🇳🇱Amsterdam, Netherlands
Leiden University Medical Center
🇳🇱Leiden, Netherlands
Christie Hospital N.H.S. Trust
🇬🇧Manchester, England, United Kingdom
Middlesex Hospital- Meyerstein Institute
🇬🇧London, England, United Kingdom
St. James's Hospital
🇬🇧Leeds, England, United Kingdom
University Medical Center Nijmegen
🇳🇱Nijmegen, Netherlands
Nottingham City Hospital NHS Trust
🇬🇧Nottingham, England, United Kingdom
Newcastle General Hospital
🇬🇧Newcastle Upon Tyne, England, United Kingdom