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NCT01120639 · ClinicalTrials.gov registry record · Phase 1

Phase 1-2 of Temozolomide and Hypofractionated Radiotherapy in Tx of Supratentorial Glioblastoma Multiform

A Phase 1 study, sponsored by Stanford University.

Completed
Registry status
Phase 1
Development phase
30
Enrollment target

NCT01120639: Completed Phase 1 study, sponsored by Stanford University.

NCT01120639 is a Phase 1 study that has completed, run by Stanford University. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT01120639, a Phase 1 study, has completed, sponsored by Stanford University.

COMPLETED
Registry status
Phase 1
Development phase
30 participants
Enrollment target

Study Summary

The purpose of this study is to investigate the safety and effectiveness of a combination treatment for glioblastoma multiforme utilizing radiotherapy plus the FDA-approved chemotherapy drug temozolomide

Primary Outcome

The maximum-tolerated dose (MTD) of study treatment (temozolomid plus hypofractionated radiotherapy administered as 5 fractions) is defined as either: * The highest radiation dose per protocol, or * The radiation dose at which dose-limiting toxicities (DLTs) occurred in ≥ 2 of 3 participants at a dose level, and/or ≥ 2 of 6 participants, at a dose level. Dose-limiting toxicity (DLT) was defined as a treatment-related (with possible, probable or definite attribution) Grade 3 to 5 CNS toxicity \

Interventions

  • DRUG Temozolomide
  • PROCEDURE Stereotactic Radiosurgery (SRS)

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2010-04
Est. Completion 2020-11-15
Phase Phase 1
Stanford University

1,744 total trials

What the finished NCT01120639 record still lists

NCT01120639 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).

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

NCT01120639 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01120639 about?

NCT01120639 is a clinical study titled "Phase 1-2 of Temozolomide and Hypofractionated Radiotherapy in Tx of Supratentorial Glioblastoma Multiform". The purpose of this study is to investigate the safety and effectiveness of a combination treatment for glioblastoma multiforme utilizing radiotherapy plus the FDA-approved chemotherapy drug temozolomide

What is the current status of trial NCT01120639?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2010-04. Estimated completion is 2020-11-15.

What interventions are being tested in trial NCT01120639?

The interventions under investigation include: Temozolomide (DRUG), Stereotactic Radiosurgery (SRS) (PROCEDURE).

Who is sponsoring clinical trial NCT01120639?

This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01120639's enrollment target sits among peer trials

30 1332nd of 2000 higher than 561 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 NCT01120639, the US trial registry maintained by the National Library of Medicine. NCT01120639 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.