NCT03477513

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 26, 2018

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2026

Completed
Last Updated

July 8, 2026

Status Verified

July 1, 2026

Enrollment Period

8.1 years

First QC Date

March 20, 2018

Last Update Submit

July 7, 2026

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (1)

  • Adverse Events

    2 years

Study Arms (1)

Single Arm

EXPERIMENTAL

Dose-escalated radiation therapy

Radiation: Radation Therapy

Interventions

Radation TherapyRADIATION

Personalized Radiation Therapy

Single Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Akbari H, Mohan S, Liu F, Jiang C, Fathi Kazerooni A, Berger M, Rathore S, Bilello M, Sako C, Garcia J, Brem S, Bakas S, Mamourian E, Pepin A, James P, Dorsey J, Singh A, Parker D, Verma R, Cao Q, Bagley SJ, Desai A, O'Rourke DM, Shinohara RT, Nasrallah MP, Teo BK, Kurtz G, Shukla G, Alonso-Basanta M, Lustig RA, Davatzikos C. Personalized machine learning-guided radiation dose escalation in newly diagnosed glioblastoma: prospective pilot study. Nat Commun. 2026 May 13. doi: 10.1038/s41467-026-72545-y. Online ahead of print.

    PMID: 42129213DERIVED

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Michelle Alonso-Basanta, MD

    Abramson Cancer Center at Penn Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2018

First Posted

March 26, 2018

Study Start

March 1, 2018

Primary Completion

April 1, 2026

Study Completion

May 21, 2026

Last Updated

July 8, 2026

Record last verified: 2026-07

Locations

US(1)