← Back to Search

Chemo-Radiation for Glioblastoma

Phase 1 & 2

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 9 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

Select...

My liver and kidney tests are within normal limits.

Select...

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

Select...

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

Select...

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

Select...

I have received radiation treatment of 50Gy or more.

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

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

Primary outcome measures

Change in Absolute Lymphocyte Count

Overall survival (OS)

Secondary outcome measures

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

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

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 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

John FlickingerLead Sponsor

John Flickinger, MDPrincipal InvestigatorUniversity of Pittsburgh

Media Library

Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04019262 — Phase 1 & 2

$Glioblastoma Research Study Groups: 40 Gy in 15 fractions, 25 Gy in 5 fractions$

Glioblastoma Clinical Trial 2023: Radiation Therapy Highlights & Side Effects. Trial Name: NCT04019262 — Phase 1 & 2

Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04019262 — Phase 1 & 2

Frequently Asked Questions

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

Is this research pioneering in its methodology?

"In 2002, Schering-Plough initiated the first research trial for 25 Gy in 5 fractions. Subsequently, it was approved and granted Phase 2 drug approval after the 60 patient study concluded. Currently there are 207 active trials with 935 cities across 36 countries contributing to this large sample size."

Answered by AI

How is 25 Gy in 5 fractions typically administered to treat medical conditions?

"25 Gray administered in 5 separate treatments is a common way to manage nitrosourea treatment. Additionally, the same protocol can be used for various other cases including refractory neuroblastoma and advanced mycosis fungoides."

Answered by AI

Could you provide insight into prior investigations on 25 Gy in 5 fractions?

"At present, 207 clinical trials are underway searching for the efficacy of 25 Gy in 5 fractions. Of these studies, 24 are currently in phase 3 and mostly based around Seoul-Songpa; however, there is a total of 4752 sites that have operations related to this treatment running."

Answered by AI

How many participants is this trial accommodating?

"Affirmative. According to the information presented on clinicaltrials.gov, this medical trial is still recruiting participants having been initially posted in December 2021 and last updated in January 2022. 40 individuals are needed for testing at one site."

Answered by AI

Are there remaining opportunities for individuals to join this experiment?

"This clinical research study, which was initially advertised on 14th December 2021, is currently seeking participants. The last update to this trial's information occurred on 6th January 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Short Course Chemo-Radiation Therapy for Patients With Newly Diagnosed Glioblastoma

John Flickinger 2021. "Short Course Chemo-Radiation Therapy for Patients With Newly Diagnosed Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04019262.

All > Recurrent Glioblastoma > Glioblastoma Multiforme