TRUSTS (EORTC 62091)

• Research type

  Research Study

• Full title

  TRUSTS (EORTC 62091): 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 Tissue Sarcoma

• IRAS ID

  74439

• Contact name

  Michael Gordon Leahy

• Sponsor organisation

  EORTC (European Organisation for Research and Treatment of Cancer

• Eudract number

  2009-014889-26

• Clinicaltrials.gov Identifier

  NCT01189253

• Research summary

  The principal objective of the trial is to evaluate whether trabectedin given as 1st line chemotherapy for advanced / metastatic soft tissue sarcoma prolongs progression free survival, as compared to doxorubicin. In step 1 (phase IIb), patients will be randomized between doxorubicin, trabectedin (3 hrs IV) and trabectedin (24 hrs IV); one of the trabectedin arms will be dropped at the end of this step, and a futility stopping rule will be applied. In step 2 (phase III): additional patients will be randomized between the trabectedin schedule selected at the end of step 1, and doxorubicin.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/NW/0666

• Date of REC Opinion

  15 Dec 2011

• REC opinion

  Further Information Favourable Opinion