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NCT03477513 Clinical Trial

Personalized Radiation Therapy for GBM

Glioblastoma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03477513
Other study ID # UPCC 24317
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 1, 2018
Est. completion date June 30, 2025

Study information
Verified date June 2024
Source Abramson Cancer Center at Penn Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 20
Est. completion date June 30, 2025
Est. primary completion date May 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Radiation:
• Radation Therapy
Personalized Radiation Therapy

Locations
Country Name City State
United States Abramson Cancer Center of the University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Abramson Cancer Center at Penn Medicine

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse Events 2 years
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