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Radiation and Temozolomide vs. PCV Chemotherapy for Brain Tumor

Phase 3
Recruiting
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Tumor tissue must show co-deletion of chromosomes 1p and 19q; acceptable methods for determination of 1p/19q loss include FISH, genomic sequencing, or methylomic analyses
Tumor must show evidence of IDH mutation by immunohistochemistry or genomic analyses
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 16 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Study Summary

This trial is testing whether giving radiation therapy with temozolomide drugs is more effective in treating brain tumors than giving radiation with another type of drug.

Who is the study for?
This trial is for patients with newly diagnosed anaplastic glioma or low grade glioma who have had surgery at least 2 weeks prior and are willing to provide tissue samples. They must not have received previous radiation or chemotherapy, be able to complete tests personally, and agree to use contraception. Excluded are those with severe diseases, recent hepatitis, pregnant/nursing women, history of other cancers within 5 years, heart issues within 6 months, HIV on retroviral therapy.Check my eligibility
What is being tested?
The study compares two treatments: one combines radiation therapy with temozolomide (both during and after radiation), while the other uses radiation followed by PCV chemotherapy (vincristine, CCNU/lomustine, procarbazine). The goal is to determine which treatment is more effective in stopping tumor growth in brain tumors like anaplastic glioma or low grade glioma.See study design
What are the potential side effects?
Possible side effects include fatigue from radiotherapy; nausea, vomiting, hair loss from temozolomide; and blood count changes from PCV chemo. Each drug can also cause unique reactions such as constipation or peripheral neuropathy from vincristine and lung problems from lomustine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My tumor has a specific genetic feature (loss of parts of chromosomes 1p and 19q).
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My tumor has an IDH mutation.
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My brain tumor is grade II or III with specific genetic changes.
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My brain tumor is a mixed glioma with specific genetic features (1p and 19q co-deletion).
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I am not pregnant or have confirmed it with a test.
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I had surgery over 2 weeks ago and have recovered well.
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My tumor has specific genetic changes, 1p/19q co-deletion and IDH mutation.
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My low-grade brain tumor is considered high-risk.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 16 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 16 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free survival
Secondary outcome measures
Objective tumor response defined as a complete response or partial response
Overall survival
Time to neurocognitive progression, assessed using the Hopkins Verbal Learning Test-Revised for Free Recall, Delayed Recall, and Delayed Recognition; the Controlled Oral Word Association test; and the Trail Making Test Part A or B
+2 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B (RT, temozolomide)Experimental Treatment3 Interventions
Patients undergo RT as in arm I and receive temozolomide PO QD on days 1-5 for 5-7 weeks. Beginning 4 weeks after completion of concurrent chemoradiotherapy, patients receive adjuvant temozolomide PO QD days 1-5. Treatment with adjuvant temozolomide repeats every 4 weeks for 6-12 courses in the absence of disease progression and unacceptable toxicity.
Group II: Arm A (RT, procarbazine, lomustine, vincristine)Experimental Treatment4 Interventions
Patients undergo 3D-CRT or IMRT on days 1-5 for 5-7 weeks. Patients also receive procarbazine hydrochloride PO on days 8-21, lomustine PO on day 1 and vincristine sulfate IV on days 8 and 29 of courses 3-8. Treatment repeats every 6-7 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
vincristine
2005
Completed Phase 4
~3840
radiotherapy
2007
Completed Phase 4
~3100
CCNU
2014
Completed Phase 3
~250

Find a Location

Who is running the clinical trial?

Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
217,273 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,579 Previous Clinical Trials
41,224,176 Total Patients Enrolled
Canadian Cancer Trials GroupNETWORK
122 Previous Clinical Trials
67,192 Total Patients Enrolled

Media Library

Radiotherapy Clinical Trial Eligibility Overview. Trial Name: NCT00887146 — Phase 3
Brain Tumor Research Study Groups: Arm B (RT, temozolomide), Arm A (RT, procarbazine, lomustine, vincristine)
Brain Tumor Clinical Trial 2023: Radiotherapy Highlights & Side Effects. Trial Name: NCT00887146 — Phase 3
Radiotherapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT00887146 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what other medical diagnoses is concomitant temozolomide (TMZ) usually prescribed?

"Stage III Hodgkin's disease is often treated with concomitant temozolomide (TMZ). This medication is also known to be effective in treating other conditions such as anaplastic astrocytoma, acquired immunodeficiency syndrome, and advanced thymoma."

Answered by AI

Is it legal to take temozolomide (TMZ) alongside other medications?

"There is prior clinical data supporting the safety of combining temozolomide (TMZ) with other cancer treatments, so it received a score of 3."

Answered by AI

How many people are participating in this research project?

"Yes, you are correct. The trial is currently ongoing and recruiting patients. According to the clinicaltrials.gov website, this study was originally posted on September 1st, 2009 and was last updated on March 22nd, 2022. They are looking for 360 patients across 100 different locations."

Answered by AI

Are there any other ongoing trials that are also testing temozolomide (TMZ)?

"The first recorded clinical trial involving concomitant temozolomide (TMZ) was conducted in 2001 at the UCSF Helen Diller Family Comprehensive Cancer Center. As of now, 687 such trials have been completed with 460 more presently underway. Many of these active trials are based out of Peoria, Illinois."

Answered by AI

Where are potential participants able to enroll in this research?

"This trial is currently taking place at 100 different medical centres around the world, some of which include OSF Saint Francis Medical Center in Peoria, Tom Baker Cancer Centre in Calgary, and Thomas Jefferson University Hospital in Philadelphia."

Answered by AI

Are recruitment efforts for this research study ongoing?

"From what is available on clinicaltrials.gov, it appears that the research team is still enrolling patients for this study. The earliest posting date was September 1st 2009 with the latest update March 22nd 2022. They hope to have 360 people participate from 100 different locations."

Answered by AI

Who else is applying?

What site did they apply to?
UT Southwestern/Simmons Cancer Center-Dallas
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

Astrositoma. Pilositico grado 1 de la OMS confio en que este trial nos puede dar mejor calidad de vida y un futuro a mi hijo de 10 anos.
PatientReceived no prior treatments
~35 spots leftby Oct 2025