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

NCT00204568 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2013-01-08

No results posted yet for this study

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).

Conditions

  • Sarcoma, Soft Tissue

Interventions

DRUG

Adriamycin

60 mg/m2, d1, W d22

DRUG

Trofosfamide

300 mg absolute d1-7, followed by 150 mg absolute continuously

Sponsors & Collaborators

  • Arbeitsgemeinschaft fur Internistische Onkologie

    collaborator OTHER

  • German Sarcoma Group

    collaborator OTHER

  • French Sarcoma Group

    collaborator OTHER

  • University Hospital Schleswig-Holstein

    lead OTHER

Principal Investigators

  • Joerg T. Hartmann, MD · University Medical Center , Comprehensive Cancer Center North, Christian-Albrechts-University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-08-31
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00204568 on ClinicalTrials.gov