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NCT01189253 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by European Organisation for Research and Treatment of Cancer - EORTC.

Terminated
Registry status
Phase 2
Development phase
133
Enrollment target

NCT01189253 is a Phase 2 study that was terminated before completion, run by European Organisation for Research and Treatment of Cancer - EORTC. The registered enrollment target is 133 participants.

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The verdict

NCT01189253, a Phase 2 study, was terminated before completion, sponsored by European Organisation for Research and Treatment of Cancer - EORTC.

TERMINATED
Registry status
Phase 2
Development phase
133 participants
Enrollment target

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.

Interventions

  • OTHER laboratory biomarker analysis
  • PROCEDURE quality-of-life assessment
  • DRUG doxorubicin hydrochloride
  • DRUG trabectedin

Trial Details

FieldValue
Enrollment Target 133 participants
Start Date 2011-05
Est. Completion 2015-06
Phase Phase 2

What the Registry Record Tells You About NCT01189253

The ClinicalTrials.gov registry entry for NCT01189253 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 133 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is European Organisation for Research and Treatment of Cancer - EORTC, which has 15 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which laboratory biomarker analysis is the first listed.

NCT01189253 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01189253 about?

NCT01189253 is a clinical study titled "Doxorubicin Hydrochloride or Trabectedin in Treating Patients With Previously Untreated Advanced or Metastatic Soft Tissue Sarcoma". 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 ...

What is the current status of trial NCT01189253?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 133 participants. The study started on 2011-05. Estimated completion is 2015-06.

What interventions are being tested in trial NCT01189253?

The interventions under investigation include: laboratory biomarker analysis (OTHER), quality-of-life assessment (PROCEDURE), doxorubicin hydrochloride (DRUG), trabectedin (DRUG).

Who is sponsoring clinical trial NCT01189253?

This trial is sponsored by European Organisation for Research and Treatment of Cancer - EORTC, which has 15 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.