Personalized Radiation Therapy for GBM

Sponsor
Abramson Cancer Center of the University of Pennsylvania (Other)
Overall Status
Recruiting
CT.gov ID
NCT03477513
Collaborator
(none)
20
1
1
63
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Radation Therapy
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 1, 2018
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Single Arm

Dose-escalated radiation therapy

Radiation: Radation Therapy
Personalized Radiation Therapy

Outcome Measures

Primary Outcome Measures

  1. Adverse Events [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Abramson Cancer Center of the University of Pennsylvania Philadelphia Pennsylvania United States 19104

Sponsors and Collaborators

  • Abramson Cancer Center of the University of Pennsylvania

Investigators

  • Principal Investigator: Robert Lustig, MD, Abramson Cancer Center of the University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT03477513
Other Study ID Numbers:
  • UPCC 24317
First Posted:
Mar 26, 2018
Last Update Posted:
Apr 1, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 1, 2022