Back to resultsPersonalized Radiation Therapy for GBM
Primary Purpose
Glioblastoma
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Radation Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Glioblastoma
Eligibility Criteria
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
Sites / Locations
- Abramson Cancer Center of the University of Pennsylvania
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
Dose-escalated radiation therapy
Outcomes
Primary Outcome Measures
Adverse Events
Secondary Outcome Measures
Full Information
NCT ID
NCT03477513
First Posted
March 20, 2018
Last Updated
June 30, 2023
Sponsor
Abramson Cancer Center at Penn Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03477513
Brief Title
Personalized Radiation Therapy for GBM
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Experimental
Arm Description
Dose-escalated radiation therapy
Intervention Type
Radiation
Intervention Name(s)
Radation Therapy
Intervention Description
Personalized Radiation Therapy
Primary Outcome Measure Information:
Title
Adverse Events
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Alonso-Basanta, MD
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Personalized Radiation Therapy for GBM
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