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Chemo-Radiation for Glioblastoma

Phase 1 & 2

Waitlist Available

Led By John Flickinger, MD

Research Sponsored by John Flickinger

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Karnofsky Performance Status (KPS) below 60 or ECOG of 3 or 4

Liver function tests and creatinine not greater than twice ULN

Must not have

Prior radiotherapy to involved site in brain.

Karnofsky Performance Status less than 50

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 9 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing two radiation schedules with temozolomide chemo-radiotherapy for glioblastoma patients.

Who is the study for?

Adults diagnosed with WHO Grade IV Glioblastoma who can consent, have acceptable liver and kidney function tests, normal blood counts, are not pregnant or breastfeeding, and do not have distant cancer spread. Prior chemotherapy is allowed but no prior radiotherapy to the brain. Participants must be able to follow the study plan as assessed by the investigator.

What is being tested?

The trial explores two established radiation schedules for glioblastoma treatment: one delivering 40 Gy in 15 fractions and another with 25 Gy in 5 fractions. Both use concurrent temozolomide (a chemotherapy drug). Patients will be randomly assigned to either schedule to compare effectiveness.

What are the potential side effects?

Possible side effects include fatigue, skin irritation at the radiation site, nausea, headaches, hair loss from radiation therapy; temozolomide may cause nausea/vomiting, constipation/diarrhea, loss of appetite/weight changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have significant difficulty with daily activities or cannot do them at all.

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My liver and kidney tests are within normal limits.

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My cancer has not spread to distant parts of my body.

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I am 18 or older and can sign a consent form.

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My diagnosis is Grade IV Glioblastoma, confirmed before any radiotherapy.

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I have received radiation treatment of 50Gy or more.

Exclusion Criteria

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

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I have had radiation therapy on my brain before.

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I need considerable assistance and medical care.

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My cancer has spread to distant parts of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 9 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 9 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 9 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Absolute Lymphocyte Count

Overall survival (OS)

Secondary study objectives

Progression free survival (PFS) - 25 Gy in 5 fractions

Progression free survival (PFS) - 40 Gy in 15 fractions

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Active Control

Group I: 40 Gy in 15 fractionsActive Control2 Interventions

Patients randomized to 40 Gy in 15 fractions will receive 75 mg/m\^2 temozolomide per day for 15 days starting the first day of radiotherapy. This treatment will be followed by standard monthly 5 day cycles at 150 mg/m\^2 for upto 1 year.

Group II: 25 Gy in 5 fractionsActive Control2 Interventions

Patients randomized to 25 Gy in 5 fractions will receive 150 mg/m\^2 temozolomide per day for 5 days starting the first day of radiotherapy. This treatment will be followed by standard monthly 5 day cycles at 150 mg/m\^2 for upto 1 year.

0 / 9Eligibility criteria met