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COMPLETED Phase 1

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

NCT00532948 · View on ClinicalTrials.gov ↗

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

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

758 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00532948

The ClinicalTrials.gov registry entry for NCT00532948 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00532948 reports 9 study locations spanning 8 distinct geographic areas — top geographies include Pennsylvania, California, District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00532948?

The interventions under investigation include: capecitabine [Xeloda] (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00532948?

This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial