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NCT00304031 · ClinicalTrials.gov registry record · Phase 3

Radiation Therapy (RT) and Temozolomide (TMZ) in Treating Patients With Newly Diagnosed Glioblastoma or Gliosarcoma

A Phase 3 study, sponsored by Radiation Therapy Oncology Group.

Completed
Registry status
Phase 3
Development phase
1,173
Enrollment target

NCT00304031 is a Phase 3 study that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 1,173 participants.

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The verdict

NCT00304031, a Phase 3 study, has completed, sponsored by Radiation Therapy Oncology Group.

COMPLETED
Registry status
Phase 3
Development phase
1,173 participants
Enrollment target

Study Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with temozolomide may kill more tumor cells. It is not yet known which schedule of temozolomide when given together with radiation therapy is more effective in treating glioblastoma or gliosarcoma. PURPOSE: This randomized phase III trial is studying two different schedules of temozolomide to compare how well they work when given together with radiation therapy in treating patients with newly diagnosed glioblastoma or gliosarcoma.

Interventions

  • DRUG Concurrent temozolomide
  • RADIATION Concurrent radiation therapy
  • DRUG 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle
  • DRUG 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle

Trial Details

FieldValue
Enrollment Target 1,173 participants
Start Date 2006-01
Est. Completion 2016-12
Phase Phase 3

Sponsor

Radiation Therapy Oncology Group

144 total trials

What the Registry Record Tells You About NCT00304031

The ClinicalTrials.gov registry entry for NCT00304031 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,173 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Radiation Therapy Oncology Group, which has 144 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Concurrent temozolomide is the first listed.

NCT00304031 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00304031 about?

NCT00304031 is a clinical study titled "Radiation Therapy (RT) and Temozolomide (TMZ) in Treating Patients With Newly Diagnosed Glioblastoma or Gliosarcoma". RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with temozolomide may...

What is the current status of trial NCT00304031?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,173 participants. The study started on 2006-01. Estimated completion is 2016-12.

What interventions are being tested in trial NCT00304031?

The interventions under investigation include: Concurrent temozolomide (DRUG), Concurrent radiation therapy (RADIATION), 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle (DRUG), 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle (DRUG).

Who is sponsoring clinical trial NCT00304031?

This trial is sponsored by Radiation Therapy Oncology Group, which has 144 total clinical trials registered on ClinicalTrials.gov.

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

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.