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NCT00532948 · ClinicalTrials.gov registry record · Phase 1

A Study of Xeloda (Capecitabine) Plus Radiation Therapy in Children With Newly Diagnosed Gliomas

A Phase 1 study of Glioma, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 1
Development phase
24
Enrollment target
9
Study locations

NCT00532948 is a Phase 1 study of Glioma that has completed, run by Hoffmann-La Roche. The registered enrollment target is 24 participants, below the 210-participant average among 87 other Glioma trials with a reported enrollment target (89% lower). The trial reports 9 study locations across 8 states.

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The verdict

NCT00532948, a Phase 1 study of Glioma, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target
9
Study locations

Study Summary

This single arm study will assess the maximum tolerated dose, and dose-limiting toxicities, of Xeloda administered concurrently with radiation therapy, in children with newly diagnosed diffuse intrinsic brain stem gliomas and high grade gliomas. Xeloda will be administered twice daily, at a starting dose of 500mg/m2 bid, beginning within 24 hours of the start of radiation therapy. Subsequent dose escalations will be in increments of 30%, using a standard dose escalation schema. Post-radiation therapy with Xeloda will continue after a 2 week break. The anticipated time on study treatment is 3-12 months, and the target sample size will not exceed 30 evaluable patients.

Conditions Studied

Glioma

Interventions

  • DRUG capecitabine [Xeloda]

Study Locations (9)

Pennsylvania

  • - Philadelphia
  • - Pittsburgh

California

  • - San Francisco

District of Columbia

  • - Washington D.C.

Illinois

  • - Chicago

Massachusetts

  • - Boston

North Carolina

  • - Durham

Texas

  • - Houston

Washington

  • - Seattle

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2007-05
Est. Completion 2010-10
Phase Phase 1

Sponsor

Hoffmann-La Roche

909 total trials

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What the Registry Record Tells You About NCT00532948

The ClinicalTrials.gov registry entry for NCT00532948 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 210-participant average among 87 other Glioma trials with a reported enrollment target (89% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Glioma appearing as the primary indexed condition, and to 1 intervention - of which capecitabine [Xeloda] is the first listed.

NCT00532948 reports 9 study locations spanning 8 distinct geographic areas - top geographies include Pennsylvania, California, District of Columbia.

Frequently Asked Questions

What is clinical trial NCT00532948 about?

NCT00532948 is a clinical study titled "A Study of Xeloda (Capecitabine) Plus Radiation Therapy in Children With Newly Diagnosed Gliomas". This single arm study will assess the maximum tolerated dose, and dose-limiting toxicities, of Xeloda administered concurrently with radiation therapy, in children with newly diagnosed diffuse intrinsic brain stem gliomas and high grade gliomas. Xeloda will be administered twice daily, at a starting...

What is the current status of trial NCT00532948?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2007-05. Estimated completion is 2010-10.

What conditions does trial NCT00532948 study?

This clinical trial studies the following conditions: Glioma.

What interventions are being tested in trial NCT00532948?

The interventions under investigation include: capecitabine [Xeloda] (DRUG).

Who is sponsoring clinical trial NCT00532948?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00532948 being conducted?

This trial has 9 study locations across California, District of Columbia, Illinois, Massachusetts, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.