NCT05718466

Brief Summary

This clinical trial is a prospective study of radiosurgery treatment for progressive GBM to test 1)the efficacy of radiosurgery for recurrent/progressive GBM compared to chemotherapy , and 2) the role of diffusion-weighted image (DWI) to predict the early tumor progression and treatment response.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2010

Longer than P75 for phase_3

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

November 1, 2010

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
6.2 years until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
5 months until next milestone

Results Posted

Study results publicly available

July 17, 2023

Completed
Last Updated

July 17, 2023

Status Verified

June 1, 2023

Enrollment Period

6.1 years

First QC Date

February 26, 2014

Results QC Date

June 23, 2023

Last Update Submit

June 23, 2023

Conditions

Recurrent or Progressive Glioblastoma

Keywords

glioblastoma

Outcome Measures

Primary Outcomes (3)

  • Local Tumor Control

    2 months

  • Overall Survival

    12 months

  • Progression Free Survival

    12 months

Study Arms (2)

Fractionated Radiosurgery and Bevacizumab

EXPERIMENTAL

FRS and Bev followed by Bev combined either Irinotecan or Temozolamide or Carboplatin or Etoposide until progression

Drug: BevacizumabDrug: ChemotherapyRadiation: Fractionated radiosurgery

Bev with Chemo

ACTIVE COMPARATOR

Bev combined either Irinotecan or Temozolomide or Carboplatin or Etoposide until progression

Drug: BevacizumabDrug: Chemotherapy

Interventions

BevacizumabDRUG
Bev with ChemoFractionated Radiosurgery and Bevacizumab
ChemotherapyDRUG
Also known as: Either irinotecan or temozolomide or carboplatin or etoposide
Bev with ChemoFractionated Radiosurgery and Bevacizumab
Fractionated radiosurgeryRADIATION
Fractionated Radiosurgery and Bevacizumab

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically proven intracranial glioblastoma multiforme with pathologic or imaging confirmation of tumor progression or regrowth after failure of two previous treatment regimens
  • Initial low-grade glioma and a subsequent diagnosis of glioblastoma or gliosarcoma
  • History and physical exam, including neurologic examination, within 4 weeks prior to registration

You may not qualify if:

  • Warfarin or LMW heparin patients must have no active bleeding or pathological condition that carries a high risk of bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

RecurrenceGlioblastoma

Interventions

BevacizumabDrug TherapyTemozolomideCarboplatinEtoposide

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsAstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsTherapeuticsDacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCoordination ComplexesPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsGlucosidesGlycosidesCarbohydrates

Results Point of Contact

Title
Marissa Gilbert
Organization
Henry Ford Health System
mgilber6@hfhs.org
313-556-8422

Study Officials

  • Farzan Siddiqui, MD

    Henry Ford Hospital

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Radiation Oncologist

Study Record Dates

First Submitted

February 26, 2014

First Posted

February 8, 2023

Study Start

November 1, 2010

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

July 17, 2023

Results First Posted

July 17, 2023

Record last verified: 2023-06

Locations

US(1)