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

NCT04019262 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: HCC 19-022
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glioblastoma

Keywords

Chemo-Radiation Therapy; temozolomide; lymphocytopenia

Outcome Measures

Primary Outcomes (2)

• Overall survival (OS)

  The length of time from the start of treatment that patients remain alive.

  Up to 9 years

• Change in Absolute Lymphocyte Count

  Differences in absolute lymphocyte count (total lymphocyte count \<800 - 500/mm\^3 \<0.8 - 0.5 x 10\^9 /L) / total # patients, during treatment.

  From baseline up to 5 years.

Secondary Outcomes (2)

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

  Up to 9 years

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

  Up to 9 years

Study Arms (2)

40 Gy in 15 fractions

ACTIVE COMPARATOR

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.

Radiation: Radiation Therapy; Drug: Temozolomide Oral Product

25 Gy in 5 fractions

ACTIVE COMPARATOR

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: Radiation Therapy; Drug: Temozolomide Oral Product

Interventions

Radiation Therapy RADIATION

Radiation

25 Gy in 5 fractions; 40 Gy in 15 fractions

Temozolomide Oral Product DRUG

Oral Temozolomide (150mg/m\^2 or 75 mg/m\^2)

25 Gy in 5 fractions; 40 Gy in 15 fractions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Evidence of distant metastases on any staging or imaging modality
• Women who are breast feeding, or have a positive pregnancy test (reproductive age should use effective birth control during study)
• Any co-morbidity or condition of sufficient severity to limit full compliance with the protocol per assessment by the principal investigator.
• Karnofsky Performance Status less than 50
• Prior radiotherapy to involved site in brain.

Sponsors & Collaborators

• John Flickinger: lead

Study Sites (1)

University of Pittsburgh Medical Center, Radiation Oncology

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Glioblastoma; Lymphopenia

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• John Flickinger, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Radiation Oncology & Neurosurgery

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: July 15, 2019
• Study Start: December 14, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)