Spots Global Cancer Trial Database for A Trial Comparing Two Medications as First Treatment in Elderly Patients With Metastatic or Advanced Soft Tissue Sarcoma
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Trial Identification
Brief Title: A Trial Comparing Two Medications as First Treatment in Elderly Patients With Metastatic or Advanced Soft Tissue Sarcoma
Official Title: A Randomized Phase II Trial Comparing Pazopanib With Doxorubicin as First Line Treatment in Elderly Patients With Metastatic or Advanced Soft Tissue Sarcoma
Study ID: NCT01861951
Conditions
Study Description
Brief Summary: Patients with a locally advanced or metastatic (i.e., there are already metastases of the diagnosed tumor in the body outside the primary lesion) soft tissue sarcoma will be recruited for this study. The minimum age to enter the study is 60 years. Therapy with doxorubicin is the mainstay of palliative chemotherapy for these patients, which is associated with hematological toxicity and an increase of the infection rate. Pazopanib is known to rarely induce hematological toxicity or to trigger infection. We therefore assume that pazopanib exerts similar activity while decreasing neutropenia and neutropenic fever. Pazopanib is already approved in the U.S. and Europe for the treatment of advanced soft tissue sarcoma. Doxorubicin and pazopanib will be randomly allocated to either receive doxorubicin or pazopanib in a phase II clinical trial. The aim of this study is to measure the treatment effect (reduction in tumor size or tumor stabilization) for both drugs, as well as the survival rate, and the duration of tumor control by the different therapies. A further objective is to measure the quality of life by standardized questionnaires throughout the course of treatment.
Detailed Description:
Eligibility
Minimum Age: 60 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University Hospitals Leuven, Leuven Cancer Institute, Dept. of General Medical Oncology, Leuven, Flemish Brabant, Belgium
Heidelberg University Hospital, Department of Internal Medicine, Hematology, Oncology and Rheumatology, Heidelberg, Baden-Wuerttemberg, Germany
University Medical Centre Mannheim, Surgical oncology, Mannheim, Baden-Wuerttemberg, Germany
Medical University Tuebingen, Center for Soft Tissue Sarcoma, GIST and Bone Tumors, Tuebingen, Baden-Wuerttemberg, Germany
LMU University hospital Munich Grosshadern, Medical Dept. III, Munich, Bavaria, Germany
Hannover Medical School, Department of Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Hanover, Lower Saxony, Germany
University Hospital RWTH Aachen, Medical Dept. IV, Aachen, North Rhine-Westphalia, Germany
University Hospital Cologne, Cologne, North Rhine-Westphalia, Germany
University Hospital Essen, West-German Tumor Center, Essen, North Rhine-Westphalia, Germany
University Hospital Carl Gustav Carus, Internal Medicine Dept. I, Dresden, Saxony, Germany
Charité Hospital, Medical Department, Division of Hematology, Oncology and Tumor Immunology, Berlin, , Germany
Contact Details
Name: Viktor Gruenwald, MD, Prof.
Affiliation: Hannover Medical School
Role: PRINCIPAL_INVESTIGATOR
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