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NCT01252797 · ClinicalTrials.gov registry record · Phase 1

Dose Escalation/De-escalation Study of Pre-operative Stereotactic Radiosurgery for Brain Metastases(RAD 1002)

A Phase 1 study, sponsored by University of Alabama at Birmingham.

Completed
Registry status
Phase 1
Development phase
20
Enrollment target

NCT01252797: Completed Phase 1 study, sponsored by University of Alabama at Birmingham.

NCT01252797 is a Phase 1 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01252797, a Phase 1 study, has completed, sponsored by University of Alabama at Birmingham.

COMPLETED
Registry status
Phase 1
Development phase
20 participants
Enrollment target

Study Summary

This study will investigate the safety, tolerability, and effectiveness of changing the order of receiving radiation therapy for treating brain cancer. The investigators hope that changing the sequence of radiation therapy will lower the risk of cancer spreading throughout your spinal fluid, which covers your brain and spinal cord.

Primary Outcome

The maximum tolerated dose (MTD) is defined as the highest dose of stereotactic radiosurgery delivered pre-operative at which no more than 2 out of 6 patients experience a dose limiting toxicity (DLT).

Interventions

  • RADIATION Stereotactic Radiosurgery (15 Gy)
  • RADIATION Stereotactic Radiosurgery (12 Gy)

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2010-10
Est. Completion 2018-04
Phase Phase 1
University of Alabama at Birmingham

1,160 total trials

What the finished NCT01252797 record still lists

NCT01252797 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).

The record links to 0 conditions, and to 2 interventions - of which Stereotactic Radiosurgery (15 Gy) is the first listed.

NCT01252797 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01252797 about?

NCT01252797 is a clinical study titled "Dose Escalation/De-escalation Study of Pre-operative Stereotactic Radiosurgery for Brain Metastases(RAD 1002)". This study will investigate the safety, tolerability, and effectiveness of changing the order of receiving radiation therapy for treating brain cancer. The investigators hope that changing the sequence of radiation therapy will lower the risk of cancer spreading throughout your spinal fluid, which c...

What is the current status of trial NCT01252797?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2010-10. Estimated completion is 2018-04.

What interventions are being tested in trial NCT01252797?

The interventions under investigation include: Stereotactic Radiosurgery (15 Gy) (RADIATION), Stereotactic Radiosurgery (12 Gy) (RADIATION).

Who is sponsoring clinical trial NCT01252797?

This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01252797's enrollment target sits among peer trials

20 1629th of 2000 higher than 285 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 NCT01252797, the US trial registry maintained by the National Library of Medicine. NCT01252797 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.