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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%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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I have severe symptoms like headaches, seizures, or trouble thinking due to my condition.

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I can care for myself but may not be able to do active work.

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I had surgery to remove a tumor and no cancer can be seen after.

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My brain tumor is a confirmed low-grade glioma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall survival (OS)

Progression-free survival (PFS)

Secondary outcome measures

Correlation of pre-treatment 1p and 19q levels in tumor tissue samples with PFS and OS

Neurocognitive functioning as assessed at baseline, annually until disease progression, and at the time of disease progression

Quality of life as assessed by the FACT-BR questionnaire at baseline, annually until disease progression, and at the time of disease progression

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

temozolomide

2008

Completed Phase 2

~1060

3-dimensional conformal radiation therapy

2007

Completed Phase 3

~2690

intensity-modulated radiation therapy

2008

Completed Phase 3

~1490

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Eastern Cooperative Oncology GroupLead Sponsor

268 Previous Clinical Trials

150,290 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,932,613 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

Frequently Asked Questions

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

Does prior research support the use of 3-dimensional conformal radiation therapy?

"Out of the 219 clinical trials currently being conducted on 3-dimensional conformal radiation therapy, 25 are in the critical Phase 3. The majority of these trials are based in Seoul, Songpa; however, there are 4738 total locations running these studies."

Answered by AI

What is the national spread of this research project?

"This trial is currently enrolling at OSF Holy Family Medical Center in Monmouth, Illinois, Oncology Hematology Associates of Central Illinois, PC - Peoria in Peoria, Ohio, Case Comprehensive Cancer Center in Cleveland, Michigan, and many other locations."

Answered by AI

Does your research include elderly test subjects?

"In order to participate in this study, potential patients must between 18-120 years old. There are 236 other clinical trials available for patients that are under 18 and 480 for elderly patients."

Answered by AI

Is 3-dimensional conformal radiation therapy used more to target cancerous cells or non-cancerous cells?

"3-dimensional conformal radiation therapy, often used in conjunction with nitrosourea treatment, can be effective in treating a number of conditions including refractory neuroblastoma, mycosis fungoides, and refractory cancer."

Answered by AI

Have there been other clinical studies like this one previously?

"3-dimensional conformal radiation therapy has been researched since 2002. The very first clinical trial took place in 2002 and was sponsored by Schering-Plough. Following the first study in 2002, which involved 60, 3-dimensional conformal radiation therapy received its Phase 2 drug approval. Today there are 219 active studied for 3-dimensional conformal radiation therapy across 947 cities and 34 countries."

Answered by AI

How many individuals are being used as test subjects in this research?

"This particular study has finished recruiting participants. The trial was originally posted on September 11th, 2009, with the most recent edit on August 9th, 2022. 464 other studies are currently enrolling patients with glioma and 219 trials for 3-dimensional conformal radiation therapy are actively enrolling patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Radiation Therapy With or Without Temozolomide in Treating Patients With Low-Grade Glioma

2009. "Radiation Therapy With or Without Temozolomide in Treating Patients With Low-Grade Glioma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00978458.

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