Chemo-Radiation for Glioblastoma

Overseen By John Flickinger, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: John Flickinger

Must be taking: Temozolomide

Disqualifiers: Distant metastases, Pregnancy, Breastfeeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

2 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a prospective, randomized, open-label, exploratory trial of temozolomide-based chemo-radiotherapy which compares two widely used established radiation schedules with either 40 Gy in 15 fractions or 25 Gy in 5 fractions with concurrent temozolomide for both schedules in patients with glioblastoma.

Research Team

John Flickinger, MD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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.

Inclusion Criteria

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

My liver and kidney tests are within normal limits.

Patient should not be pregnant. Urine or blood β-HCG within 14 days prior to study start for females who are not at least one year post-menopausal or who have not undergone a surgical sterilization procedure

Exclusion Criteria

I have had radiation therapy on my brain before.

I am not pregnant, breastfeeding, and if of childbearing age, I am using effective birth control.

I need considerable assistance and medical care.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Chemo-radiation

Patients receive either 40 Gy in 15 fractions or 25 Gy in 5 fractions with concurrent temozolomide

1-3 weeks

5 visits per week (in-person)

Adjuvant

Standard monthly 5-day cycles of TMZ-chemo at 150 mg/m^2 per day for up to 1 year

12 months

Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 9 years

Every 1-3 months (in-person)

Treatment Details

Interventions

• Radiation Therapy
• Temozolomide

Trial Overview 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.

Participant Groups

Group I: 40 Gy in 15 fractions Active Control 2 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 fractions Active Control 2 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.

Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in United States as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Canada as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Japan as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in China as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Switzerland as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Who Is Running the Clinical Trial?

John Flickinger

Lead Sponsor

Trials

1

Recruited

2+