← Back to Search

Radiation Therapy + Temozolomide for Brain Tumor

Phase 3
Waitlist Available
Research Sponsored by Eastern Cooperative Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must currently meet ≥ 1 of the following criteria: Uncontrolled symptoms such as headaches associated with mass effect, uncontrolled seizures, focal neurological symptoms, or cognitive symptoms or deficits
Karnofsky performance status 60-100%
Must not have
No other disorder that would limit life expectancy to < 5 years
No prior radiotherapy, cytotoxic chemotherapy, radiosurgery, or investigational therapy directed at the brain tumor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial is studying radiation therapy in combination with or without temozolomide to treat patients with low-grade glioma.

Who is the study for?
This trial is for adults with low-grade glioma, a type of brain tumor. Participants must have symptoms like headaches or seizures, show tumor growth on MRIs, or be over 40 years old. They should be in good physical condition and not pregnant. People who only have well-controlled seizures or other specific health issues are excluded.
What is being tested?
The study is testing if radiation therapy works better alone or combined with temozolomide chemotherapy for treating low-grade glioma. Patients will randomly receive either just high-precision radiation therapy or the same radiation plus temozolomide.
What are the potential side effects?
Temozolomide can cause nausea, fatigue, hair loss, constipation, and risk of infection. Radiation may lead to skin irritation at the treatment site, tiredness, and mild headaches.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have severe symptoms like headaches, seizures, or trouble thinking due to my condition.
Select...
I can care for myself but may not be able to do active work.
Select...
I had surgery to remove a tumor and no cancer can be seen after.
Select...
My brain tumor is a confirmed low-grade glioma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have any health conditions that would shorten my life to less than 5 years.
Select...
I haven't had treatments like radiation or chemotherapy for my brain tumor.
Select...
I have not had radiation therapy to my head that affected my brain.
Select...
My brain tumor is not one of the less aggressive types.
Select...
I don't have any health conditions that make cancer treatment riskier.
Select...
I do not have any infections that aren't responding to treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm IIExperimental Treatment3 Interventions
Patients undergo radiotherapy as in arm I and receive concurrent oral temozolomide once daily for 5½ weeks. Beginning 28 days after completion of chemoradiotherapy, patients receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
Group II: Arm IActive Control2 Interventions
Patients undergo 3-dimensional conformal or intensity-modulated radiotherapy once daily 5 days a week for 5½ weeks (28 fractions).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
intensity-modulated radiation therapy
2008
Completed Phase 3
~1490
3-dimensional conformal radiation therapy
2007
Completed Phase 3
~2690
temozolomide
2008
Completed Phase 2
~1060

Find a Location

Who is running the clinical trial?

Eastern Cooperative Oncology GroupLead Sponsor
268 Previous Clinical Trials
151,055 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,460 Total Patients Enrolled
David Schiff, MDStudy ChairUniversity of Virginia
2 Previous Clinical Trials
124 Total Patients Enrolled

Media Library

3-dimensional conformal radiation therapy Clinical Trial Eligibility Overview. Trial Name: NCT00978458 — Phase 3
Brain Tumor Research Study Groups: Arm II, Arm I
Brain Tumor Clinical Trial 2023: 3-dimensional conformal radiation therapy Highlights & Side Effects. Trial Name: NCT00978458 — Phase 3
3-dimensional conformal radiation therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT00978458 — Phase 3
~9 spots leftby Dec 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top