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Radiation Therapy With Concomitant and Adjuvant Temozolomide Versus Radiation Therapy With Adjuvant PCV Chemotherapy in Patients With Anaplastic Glioma or Low Grade Glioma

NCT00887146 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 305

Last updated 2026-01-22

No results posted yet for this study

Summary

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. It is not yet known whether giving radiation with concomitant and adjuvant temozolomide versus radiation with adjuvant PCV is more effective in treating anaplastic glioma or low grade glioma.

Conditions

Interventions

DRUG

concomitant temozolomide (TMZ)

75 mg/m\^2, orally daily

RADIATION

radiotherapy

DRUG

procarbazine

Days 8-21: 60 mg/m\^2 orally

DRUG

adjuvant temozolomide (TMZ)

150 or 200 mg/m\^2 orally

DRUG

CCNU

Day 1: 110 mg/m\^2 orally

DRUG

vincristine

Days 8 and 29: 1.4 mg/m\^2 IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • European Organisation for Research and Treatment Center (EORTC)

    collaborator UNKNOWN

  • Canadian Cancer Trials Group

    collaborator NETWORK

  • Alliance for Clinical Trials in Oncology

    lead OTHER

Principal Investigators

  • Kurt Jaeckle, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2029-10-31
Completion
2029-10-31

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • France
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00887146 on ClinicalTrials.gov