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25 Gy in 5 fractions for Glioblastoma

University of Pittsburgh Medical Center, Radiation Oncology, Pittsburgh, PA

Radiation Therapy +1 morePhase 1 & 2RecruitingLed by John Flickinger, MDResearch Sponsored by John Flickinger

Eligibility Criteria Checklist

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

Must have

Prior radiotherapy to a dose of ≥50Gy

No signs of distant metastases

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upup to 9 years

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Study Summary

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

Eligibility Criteria

Inclusion Criteria

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

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You have received radiation treatment with a dose of 50Gy or higher in the past.

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There are no signs of cancer spreading to other parts of the body.

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You can have received any type of chemotherapy before, and your doctors may decide to give you additional treatment alongside the study drug.

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

Awards & Highlights

No Placebo-Only Group

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

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups

Active Control

Group I: 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.

Group II: 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.

0 / 3Eligibility criteria met

Find a site

Who is running the clinical trial?

John FlickingerLead Sponsor

John Flickinger, MDPrincipal Investigator

University of Pittsburgh

Media Library

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

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

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.