NCT00204568

Trofosfamide Versus Adriamycin in Elderly Patients With Soft Tissue Sarcoma (STS)

Randomized Phase II Trial of Trofosfamide vs. Adriamycin in Elderly Patients With Previously Untreated Metastatic Soft Tissue Sarcoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 117 (estimated)
• Sponsor: University Hospital Schleswig-Holstein · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

The goal of this trial is to determine whether oral continuous (metronomic) therapy with trofosfamide results in a similar rate of progression-free time after 6 months as intravenous treatment with adriamycin. In addition, the study is intended to investigate the level of toxicity associated with the two treatment regimens (safety profile).

Detailed description

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)

Conditions

• Sarcoma, Soft Tissue

Interventions

Type	Name	Description
DRUG	Adriamycin	60 mg/m2, d1, W d22
DRUG	Trofosfamide	300 mg absolute d1-7, followed by 150 mg absolute continuously

Timeline

• Start date: 2004-08-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2005-09-20
• Last updated: 2013-01-08

Locations

1 site across 1 country: Germany