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Stereotactic Radiology Versus Chemotherapy for Recurrent/Progressive Glioblastoma After Second-Line Chemotherapy

Primary Purpose

Recurrent or Progressive Glioblastoma

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Bevacizumab
Chemotherapy
Fractionated radiosurgery
Sponsored by
Henry Ford Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent or Progressive Glioblastoma focused on measuring glioblastoma

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Henry Ford Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fractionated Radiosurgery and Bevacizumab

Bev with Chemo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Local Tumor Control
Overall Survival
Progression Free Survival

Secondary Outcome Measures

Full Information

First Posted
February 26, 2014
Last Updated
June 23, 2023
Sponsor
Henry Ford Health System
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1. Study Identification

Unique Protocol Identification Number
NCT05718466
Brief Title
Stereotactic Radiology Versus Chemotherapy for Recurrent/Progressive Glioblastoma After Second-Line Chemotherapy
Official Title
Prospective Study of Stereotactic Radiosurgery Using Diffusion-Weighted Abnormality Versus Chemotherapy for Recurrent/Progressive Glioblastoma After Second-line Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent or Progressive Glioblastoma
Keywords
glioblastoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fractionated Radiosurgery and Bevacizumab
Arm Type
Experimental
Arm Description
FRS and Bev followed by Bev combined either Irinotecan or Temozolamide or Carboplatin or Etoposide until progression
Arm Title
Bev with Chemo
Arm Type
Active Comparator
Arm Description
Bev combined either Irinotecan or Temozolomide or Carboplatin or Etoposide until progression
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Other Intervention Name(s)
Either irinotecan or temozolomide or carboplatin or etoposide
Intervention Type
Radiation
Intervention Name(s)
Fractionated radiosurgery
Primary Outcome Measure Information:
Title
Local Tumor Control
Time Frame
2 months
Title
Overall Survival
Time Frame
12 months
Title
Progression Free Survival
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: • Warfarin or LMW heparin patients must have no active bleeding or pathological condition that carries a high risk of bleeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Farzan Siddiqui, MD
Organizational Affiliation
Henry Ford Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Stereotactic Radiology Versus Chemotherapy for Recurrent/Progressive Glioblastoma After Second-Line Chemotherapy

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