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Doxorubicin Hydrochloride or Trabectedin in Treating Patients With Previously Untreated Advanced or Metastatic Soft Tissue Sarcoma

NCT01189253 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2014-08-08

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride and trabectedin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether trabectedin is more effective than doxorubicin hydrochloride in treating patients with advanced or metastatic soft tissue sarcoma.

PURPOSE: This randomized phase II/III trial is studying the safety of trabectedin compared with doxorubicin hydrochloride and to see how well they work in treating patients with advanced or metastatic soft tissue sarcoma.

Conditions

  • Sarcoma

Interventions

DRUG

doxorubicin hydrochloride

DRUG

trabectedin

OTHER

laboratory biomarker analysis

PROCEDURE

quality-of-life assessment

Sponsors & Collaborators

  • Sarcoma Alliance for Research through Collaboration

    collaborator OTHER

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Nguyen Binh Bui, MD · Institut Bergonié

  • James E. Butrynski, MD · Dana-Farber Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2013-06-30
Completion
2015-06-30

Countries

  • United States
  • Austria
  • Belgium
  • Denmark
  • France
  • Germany
  • Hungary
  • Netherlands
  • Poland
  • Slovakia
  • Spain
  • Switzerland
  • United Kingdom

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 NCT01189253 on ClinicalTrials.gov