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NCT02046304 · ClinicalTrials.gov registry record · Phase 1

PP-Gemcitabine & External Beam Radiation-Sarcomas

A Phase 1 study, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 1
Development phase
41
Enrollment target

NCT02046304: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.

NCT02046304 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 41 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT02046304, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
41 participants
Enrollment target

Study Summary

The goal of this clinical research study is to find the highest safe dose of gemcitabine that can be given with radiotherapy before surgery to treat sarcoma. This study will also look at how well this treatment controls sarcoma.

Primary Outcome

The maximum tolerated dose (MTD) defined as the dose having posterior expected toxicity importance score (TIS) closest to the target 1.65 at the end of the trial.

Interventions

  • RADIATION Radiation Therapy
  • DRUG Gemcitabine

Trial Details

FieldValue
Enrollment Target 41 participants
Start Date 2001-12
Est. Completion 2015-03
Phase Phase 1
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT02046304 record still lists

NCT02046304 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower).

The record links to 0 conditions, and to 2 interventions - of which Radiation Therapy is the first listed.

NCT02046304 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02046304 about?

NCT02046304 is a clinical study titled "PP-Gemcitabine & External Beam Radiation-Sarcomas". The goal of this clinical research study is to find the highest safe dose of gemcitabine that can be given with radiotherapy before surgery to treat sarcoma. This study will also look at how well this treatment controls sarcoma.

What is the current status of trial NCT02046304?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2001-12. Estimated completion is 2015-03.

What interventions are being tested in trial NCT02046304?

The interventions under investigation include: Radiation Therapy (RADIATION), Gemcitabine (DRUG).

Who is sponsoring clinical trial NCT02046304?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02046304's enrollment target sits among peer trials

41 1125th of 2000 higher than 871 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT02046304, the US trial registry maintained by the National Library of Medicine. NCT02046304 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.