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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: TRUSTS: A Phase IIB/III Multicenter Study Comparing the Efficacy of TRabectedin Administered as a 3-Hour or 24-Hour Infusion to Doxorubicin in Patients With Advanced or Metastatic Untreated Soft Tissu

Brief 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.


Detailed Summary:

OBJECTIVES:

  • To evaluate whether trabectedin given as first-line chemotherapy for patients with previously untreated advanced or metastatic malignant soft tissue sarcoma prolongs progression-free survival as compared to doxorubicin hydrochloride.
  • To identify and validate biomarkers (including, but not limited to, XPG, BRCA1, RAD51, BRCA2, ATM and CHK1) of sensitivity to trabectedin in order to allow the selection of patients that benefit most from trabectedin treatment. (Optional translational research)

OUTLINE: This is a multicenter, phase IIB study followed by a phase III study. Patients are stratified according to institution, age at registration (< 60 years old vs ≥ 60 years old), and presence of liver metastases (yes vs no).

  • Phase IIB (step 1): Patients are randomized to 1 of 3 treatment arms.

    • Arm I: Patients receive doxorubicin hydrochloride IV on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
    • Arm II: Patients receive trabectedin IV over 3 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
    • Arm III: Patients receive trabectedin IV continuously over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

At the end of step 1, the best regimen of trabectedin will be determined. Patients receiving the non-selected tr
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Current Primary Outcome:

  • Progression-free survival as assessed by RECIST v 1.1 criteria (phase IIB and phase III)
  • Safety (phase IIB)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Overall survival (phase III)
  • Response rate and response duration (phase III)
  • Safety profile (phase III)
  • Quality of life (phase III)


Original Secondary Outcome: Same as current

Information By: European Organisation for Research and Treatment of Cancer - EORTC

Dates:
Date Received: August 25, 2010
Date Started: May 2011
Date Completion: June 2015
Last Updated: August 7, 2014
Last Verified: August 2013