Spots Global Cancer Trial Database for Doxorubicin With or Without Ifosfamide and Pegfilgrastim in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma
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Trial Identification
Brief Title: Doxorubicin With or Without Ifosfamide and Pegfilgrastim in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma
Official Title: Randomised Trial Of Single Agent Doxorubicin Versus Doxorubicin Plus Ifosfamide In The First Line Treatment Of Advanced Or Metastatic Soft Tissue Sarcoma
Study ID: NCT00061984
Conditions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy such as doxorubicin and ifosfamide use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors, such as pegfilgrastim, cause the body to make blood cells. It is not yet known whether doxorubicin alone is more effective with or without ifosfamide and pegfilgrastim in treating soft tissue sarcoma. PURPOSE: This randomized phase III trial is studying giving doxorubicin alone to see how well it works compared to giving doxorubicin together with ifosfamide and pegfilgrastim in treating patients with locally advanced or metastatic soft tissue sarcoma.
Detailed Description: OBJECTIVES: * Compare the progression-free and overall survival of patients with locally advanced or metastatic soft tissue sarcoma treated with doxorubicin with vs without ifosfamide and pegfilgrastim as first-line therapy. * Compare the response in patients treated with these regimens. * Compare the treatment-related mortality of patients treated with these regimens. * Compare the toxicity of these regimens in these patients. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to WHO performance status (0 vs 1), age group (less than 50 years of age vs 50 years of age and over), presence of liver metastases (yes vs no), histological grade (2 vs 3), and participating center. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive doxorubicin IV on day 1 (or IV continuously on days 1-3). * Arm II: Patients receive doxorubicin IV on days 1-3 and ifosfamide IV over 4 hours on days 1-4. Patients also receive pegfilgrastim subcutaneously on day 5. In both arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 8 weeks until disease progression and then every 12 weeks thereafter. PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study within 4 years.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Karl-Franzens-University Graz, Graz, , Austria
Institut Jules Bordet, Brussels, , Belgium
Universitair Ziekenhuis Antwerpen, Edegem, , Belgium
U.Z. Gasthuisberg, Leuven, , Belgium
Tom Baker Cancer Centre - Calgary, Calgary, Alberta, Canada
Cross Cancer Institute at University of Alberta, Edmonton, Alberta, Canada
Doctor H. Bliss Murphy Cancer Centre, St. John's, Newfoundland and Labrador, Canada
Margaret and Charles Juravinski Cancer Centre, Hamilton, Ontario, Canada
McGill Cancer Centre at McGill University, Montreal, Quebec, Canada
Aarhus Universitetshospital - Aarhus Sygehus, Aarhus, , Denmark
Copenhagen County Herlev University Hospital, Copenhagen, , Denmark
Institut Bergonie, Bordeaux, , France
Centre Leon Berard, Lyon, , France
CHU de la Timone, Marseille, , France
Medizinische Universitaetsklinik I at the University of Cologne, Cologne, , Germany
Universitatsklinikum Carl Gustav Carus, Dresden, , Germany
Universitaetsklinikum Essen, Essen, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Klinikum der Stadt Mannheim, Mannheim, , Germany
Klinikum der Universitaet Muenchen - Grosshadern Campus, Munich, , Germany
Southwest German Cancer Center at Eberhard-Karls-University, Tuebingen, , Germany
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, , Netherlands
University Medical Center Groningen, Groningen, , Netherlands
Leiden University Medical Center, Leiden, , Netherlands
Universitair Medisch Centrum St. Radboud - Nijmegen, Nijmegen, , Netherlands
University Medical Center Rotterdam at Erasmus Medical Center, Rotterdam, , Netherlands
National Cancer Institute - Bratislava, Bratislava, , Slovakia
Vall d'Hebron University Hospital, Barcelona, , Spain
Hospital Universitario San Carlos, Madrid, , Spain
Centre Hospitalier Universitaire Vaudois, Lausanne, , Switzerland
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust, Birmingham, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital, Leeds, England, United Kingdom
Royal Marsden - London, London, England, United Kingdom
University College of London Hospitals, London, England, United Kingdom
Northern Centre for Cancer Treatment at Newcastle General Hospital, Newcastle-Upon-Tyne, England, United Kingdom
Derriford Hospital, Plymouth, England, United Kingdom
Cancer Research Centre at Weston Park Hospital, Sheffield, England, United Kingdom
Aberdeen Royal Infirmary, Aberdeen, Scotland, United Kingdom
Edinburgh Cancer Centre at Western General Hospital, Edinburgh, Scotland, United Kingdom
Western Infirmary, Glasgow, Scotland, United Kingdom
Gartnavel General Hospital, Glasgow, Scotland, United Kingdom
Contact Details
Name: Ian R. Judson, MA, MD, FRCP
Affiliation: Institute of Cancer Research, United Kingdom
Role: STUDY_CHAIR
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