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Doxorubicin vs. Trabectedin Plus Doxorubicin in Non Operable and/or Metastatic STS

NCT01104298 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2015-10-27

No results posted yet for this study

Summary

The proposed investigation intends to explore if the combination of trabectedin and doxorubicin in the first line of treatment of advanced sarcomas obtains better results than doxorubicin monotherapy

Conditions

  • Sarcoma

Interventions

DRUG

Doxorubicin

A maximum of 6 cycles every 3 weeks of doxorubicin monotherapy 75 mg/square meter will be given in the absence of progression or not acceptable toxicity.

DRUG

Trabectedin

A maximum of 6 cycles every 3 weeks of the combination (Trabectedin 1,1 mg/square meter + doxorubicin 60 mg/square meter) will be given in the absence of progression or not acceptable toxicity.

Sponsors & Collaborators

  • Grupo Espanol de Investigacion en Sarcomas

    lead OTHER

Principal Investigators

  • Javier Martin Broto, PhM · GEIS

  • Andres Poveda, Ph.M. · GEIS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2012-12-31
Completion
2014-05-31

Countries

  • Spain

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 NCT01104298 on ClinicalTrials.gov