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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%

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

No Placebo-Only Group

Pivotal Trial

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

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any health conditions that would shorten my life to less than 5 years.

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I haven't had treatments like radiation or chemotherapy for my brain tumor.

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I have not had radiation therapy to my head that affected my brain.

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My brain tumor is not one of the less aggressive types.

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I don't have any health conditions that make cancer treatment riskier.

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I do not have any infections that aren't responding to treatment.

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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