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NCT01162278 · ClinicalTrials.gov registry record · Phase 1

Stereotactic Body Radiation Therapy (SBRT) for Patients With Hepatic Metastases

A Phase 1 study, sponsored by University of Texas Southwestern Medical Center.

Completed
Registry status
Phase 1
Development phase
60
Enrollment target

NCT01162278: Completed Phase 1 study, sponsored by University of Texas Southwestern Medical Center.

NCT01162278 is a Phase 1 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01162278, a Phase 1 study, has completed, sponsored by University of Texas Southwestern Medical Center.

COMPLETED
Registry status
Phase 1
Development phase
60 participants
Enrollment target

Study Summary

Patients that have had staging studies identifying them as AJCC stage IV with up to five liver metastases will be considered for the study. About 60 patients will take part in this study at UT southwestern, Parkland Health \& Hospital System, and Methodist Richardson Cancer Center. There are four dose cohorts for this study and each cohort will enroll a minimum of 7 to a maximum of 15 patients depending on tolerance of therapy. The treatment period will last for approximately 1 day and the follow-up portion of the study will last 5 years.

Primary Outcome

The dose of single fraction stereotactic radiotherapy will be escalated without exceeding the maximum tolerated dose in patients with hepatic metastases.

Interventions

  • RADIATION SBRT

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2010-07
Est. Completion 2017-11-25
Phase Phase 1

What the finished NCT01162278 record still lists

NCT01162278 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.

The record links to 0 conditions, and to 1 intervention - of which SBRT is the first listed.

NCT01162278 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01162278 about?

NCT01162278 is a clinical study titled "Stereotactic Body Radiation Therapy (SBRT) for Patients With Hepatic Metastases". Patients that have had staging studies identifying them as AJCC stage IV with up to five liver metastases will be considered for the study. About 60 patients will take part in this study at UT southwestern, Parkland Health \& Hospital System, and Methodist Richardson Cancer Center. There are four do...

What is the current status of trial NCT01162278?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2010-07. Estimated completion is 2017-11-25.

What interventions are being tested in trial NCT01162278?

The interventions under investigation include: SBRT (RADIATION).

Who is sponsoring clinical trial NCT01162278?

This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01162278's enrollment target sits among peer trials

60 831st of 2000 higher than 1,106 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 NCT01162278, the US trial registry maintained by the National Library of Medicine. NCT01162278 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.