Adaptive Radiotherapy for Patients With GBM (ART-GBM)

November 6, 2026 updated by: Abramson Cancer Center at Penn Medicine

ART-GBM: Feasibility Study of Adaptive Radiotherapy (ART) for Patients With Glioblastoma (GBM)

This is a single institution single arm feasibility study of MRI-guided, personalized adaptive radiation therapy with reduced margins for patients with glioblastoma.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The goal of this study is to evaluate MRI-guided adaptive radiation therapy to personalize radiotherapy planning for patients with glioblastoma, reduce margins, minimize toxicity, and improve survival.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically confirmed IDH-wildtype glioblastoma (WHO Grade 4)
  • Age ≥ 18 years
  • Karnofsky Performance Status ≥ 60
  • Planned 30 or 15 fractions of radiation therapy with or without concurrent systemic therapy
  • Ability to undergo MRI imaging with IV gadolinium contrast
  • Ability to provide written informed consent
  • Multifocal tumors permitted if clinician anticipates they will be encompassed in a single radiation plan

Exclusion Criteria:

  • Prior intracranial radiotherapy
  • Multicentric disease
  • Leptomeningeal dissemination
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MRI-Guided Adaptive Radiation Therapy

The study intervention is MRI-guided adaptive radiation therapy with reduced treatment margins among patients with glioblastoma.
Radiation: MRI-Guided Adaptive Radiation Therapy

The study intervention is MRI-guided adaptive radiation therapy with reduced treatment margins among patients with glioblastoma.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of MRI-Guided Adaptive Radiotherapy
Time Frame: 44 months

Feasibility will be defined as the proportion of patients who complete at least 2 out of 3 planned biweekly offline MRI-guided adaptations during the 6 week course of radiation therapy without any delay in scheduled treatment delivery (or 1 of the 2 planned offline adaptation during a 3 week course). Feasibility will be considered acceptable if ≥ 70% of enrolled patients meet this criterion.
44 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patterns of Failure after Adaptive Radiation Therapy
Time Frame: 44 months

Patterns of failure will be analyzed relative to the target volumes and dose distributions and categorized as central (in field), marginal, or out of field.
44 months
Overall Survival
Time Frame: 44 months

Determine overall survival following adaptive radiation therapy and compare survival outcomes with a propensity score matched historical cohort treated with standard radiotherapy.
44 months
Patient-Reported Symptom Burden, Functioning, and Quality of Life
Time Frame: 44 months

Longitudinal changes in patient reported symptoms, functional interference, neurologic function, and quality of life as assessed by validated patient reported outcome measures.
44 months
Rates of Clinician Reported Toxicity
Time Frame: 44 months

Incidence and severity of treatment related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
44 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center at Penn Medicine

Investigators

  • Principal Investigator: Emily Lebow, MD, University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

September 1, 2030

Study Completion (Estimated)

September 1, 2030

Study Registration Dates

First Submitted

November 6, 2026

First Submitted That Met QC Criteria

November 6, 2026

First Posted (Actual)

November 12, 2026

Study Record Updates

Last Update Posted (Actual)

November 12, 2026

Last Update Submitted That Met QC Criteria

November 6, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPCC 09326
  • 26-7494 (Other Identifier: University of Pennsylvania Institutional Review Board)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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