NCT03477513CompletedNot Applicable
Personalized Treatment of Glioblastoma Via Image-Guided Predictive Modeling of Recurrence: A Single-Arm, Single Institutional Pilot Prospective Study of Dose-Escalated Radiation Therapy
Abramson Cancer Center at Penn Medicine2 sites in 1 country23 target enrollmentStarted: March 1, 2018Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 23
- Locations
- 2
- Primary Endpoint
- Adverse Events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Single Arm
Experimental
Dose-escalated radiation therapy
Intervention: Radation Therapy (Radiation)
Outcomes
Primary Outcomes
Adverse Events
Time Frame: 2 years
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
Loading locations...
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