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NCT04019262Active, not recruitingPhase 1/2

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

Short Course Chemo-Radiation Therapy for Patients With Newly Diagnosed Glioblastoma: Comparison of Two Established Schedules

Source: ClinicalTrials.gov · Last updated 18 Jun 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
2 (actual)
First submitted
11 Jul 2019
Start date
14 Dec 2021
Primary completion date
31 Dec 2026
Lead sponsor
John Flickinger
Diseases
Glioblastoma
NCT number
NCT04019262

What you commit to

  • Study type: Interventional · Phase 1/2
  • Participants enrolled: 2
  • From 14 Dec 2021 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior radiotherapy to involved site in brain.

Other illness

  • Any co-morbidity or condition of sufficient severity to limit full compliance with the protocol per assessment by the principal investigator.

Age

  • Women who are breast feeding, or have a positive pregnancy test (reproductive age should use effective birth control during study)

Other

  • Patients meeting any of the following exclusion criteria are not eligible for enrollment:
  • Evidence of distant metastases on any staging or imaging modality
  • Karnofsky Performance Status less than 50

Who the study is looking for

  • Each patient must meet all of the following inclusion criteria for study enrollment:
  • Age ≥18 with ability to provide written informed consent
  • Pathologically confirmed WHO Grade IV Gliobastoma prior receiving radiotherapy
  • Prior radiotherapy to a dose of ≥50Gy
  • No signs of distant metastases
  • Baseline laboratory assessment including CBC and blood chemistry, ANC \> or equal 1500, Platelet count greater or equal 100. Liver function tests and creatinine not greater than twice ULN.
  • Patient should not be pregnant. Urine or blood β-HCG within 14 days prior to study start for females who are not atleast one year post-menopausal or who have ot undergone a surgical sterilization procedure
  • A baseline MRI scan of the brain is required to determine how much tumor is present for properly planning patient's radiotherapy.
  • Karnofsky Performance Status (KPS) below 60 or ECOG of 3 or 4
  • Any number or type of prior chemotherapy is allowed (patient may receive concurrent or adjuvant systemic therapy such as cetuximab at the discretion of the treating oncologic team).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Pittsburgh Medical Center, Radiation Oncology
Coordinator of this site? Confirm its status
PittsburghUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.