Personalized Radiation Therapy for GBM

June 30, 2023 updated by: Abramson Cancer Center at Penn Medicine

Personalized Treatment of Glioblastoma Via Image-Guided Predictive Modeling of Recurrence: A Single-Arm, Single Institutional Pilot Prospective Study of Dose-Escalated Radiation Therapy

The study is a pilot study to estimate the efficacy of personalized dose-escalation radiation therapy in patients with glioblastoma, as measured by estimating the median of progression-free survival. Toxicity, patterns of recurrence, and overall median survival will be measured as secondary endpoints. Adverse events will be monitored.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Abramson Cancer Center of the University of Pennsylvania

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

Description

Inclusion Criteria:

  • Patients with biopsy-proven WHO Grade IV glioblastoma, after gross-total or near-total resection, who are undergoing definitive chemoradiation as part of their treatment regimen
  • Age 18 or older
  • Ability to give signed informed consent
  • Karnofsky Performance Status (KPS) at least 70

Exclusion Criteria:

  • Placement of Gliadel wafers
  • Participation in another investigational trial
  • Active treatment of another malignancy

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: Single Arm
Dose-escalated radiation therapy
Radiation: Radation Therapy
Personalized Radiation Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse Events
Time Frame: 2 years
2 years

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: Michelle Alonso-Basanta, MD, Abramson Cancer Center at Penn Medicine

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 (Actual)

March 1, 2018

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

March 20, 2018

First Submitted That Met QC Criteria

March 20, 2018

First Posted (Actual)

March 26, 2018

Study Record Updates

Last Update Posted (Actual)

July 3, 2023

Last Update Submitted That Met QC Criteria

June 30, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPCC 24317

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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