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NCT00796120 · ClinicalTrials.gov registry record · Phase 3

An Efficacy and Safety Study of Trabectedin Versus Doxorubicin-Based Chemotherapy in Participants With Translocation-Related Sarcomas (TRS)

A Phase 3 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

Completed
Registry status
Phase 3
Development phase
121
Enrollment target

NCT00796120: Completed Phase 3 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

NCT00796120 is a Phase 3 study that has completed, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. The registered enrollment target is 121 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00796120, a Phase 3 study, has completed, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

COMPLETED
Registry status
Phase 3
Development phase
121 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the efficacy and safety of trabectedin compared to standard doxorubicin in participants with advanced translocation-related sarcomas (cancer of connective tissue cells) (TRS).

Primary Outcome

The PFS was assessed as median number of days from the date of randomization until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier.

Interventions

  • DRUG Doxorubicin
  • DRUG Ifosfamide
  • DRUG Trabectedin

Trial Details

FieldValue
Enrollment Target 121 participants
Start Date 2008-11
Est. Completion 2014-08
Phase Phase 3

What the finished NCT00796120 record still lists

NCT00796120 is an interventional study that assigns participants to a tested intervention. The registered 121 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower).

The record links to 0 conditions, and to 3 interventions - of which Doxorubicin is the first listed.

NCT00796120 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00796120 about?

NCT00796120 is a clinical study titled "An Efficacy and Safety Study of Trabectedin Versus Doxorubicin-Based Chemotherapy in Participants With Translocation-Related Sarcomas (TRS)". The purpose of this study is to evaluate the efficacy and safety of trabectedin compared to standard doxorubicin in participants with advanced translocation-related sarcomas (cancer of connective tissue cells) (TRS).

What is the current status of trial NCT00796120?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 121 participants. The study started on 2008-11. Estimated completion is 2014-08.

What interventions are being tested in trial NCT00796120?

The interventions under investigation include: Doxorubicin (DRUG), Ifosfamide (DRUG), Trabectedin (DRUG).

Who is sponsoring clinical trial NCT00796120?

This trial is sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00796120's enrollment target sits among peer trials

121 1619th of 2000 higher than 382 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00796120, the US trial registry maintained by the National Library of Medicine. NCT00796120 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.