Randomized Phase II Trial of Trofosfamide vs. Adriamycin in Elderly Patients With Previously Untreated Metastatic Soft Tissue Sarcoma
Group A:Adriamycin (60 mg/m2, d1, qd22) 75 mg/m2 may be applied instead of 60 mg/m2 for
patients between 60 and 70 years of age (optional) Group B:Trofosfamide (300 mg absolute
p.o. qd over 7 days, then 150 mg p.o. absolute qd continuously) In case of absence of any
toxicity during treatment with trofosfamide 150 mg absolute a dose escalation to 200 mg
absolute is allowed (optional)
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival after 6 months
Progression-free survival after 6 months
after 6 months
Yes
Joerg T. Hartmann, MD
Principal Investigator
University Medical Center , Comprehensive Cancer Center North, Christian-Albrechts-University
Germany: Federal Institute for Drugs and Medical Devices
jth_001
NCT00204568
August 2004
October 2013
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