Phase 3
N=35
Stereotactic Radiology Versus Chemotherapy for Recurrent/Progressive Glioblastoma After Second-Line Chemotherapy
Recurrent or Progressive Glioblastoma
Bottom Line
View on ClinicalTrials.gov: NCT05718466 ↗Enrolled (actual)
35
Serious AEs
25.7%
Results posted
Jul 2023
Primary outcome: Primary: Local Tumor Control — 14; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Bevacizumab (Drug); Chemotherapy (Drug); Fractionated radiosurgery (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Henry Ford Health System
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Local Tumor Control |
14; 4 | — |
| PRIMARY Overall Survival |
7.2; 4.8 | 0.11 |
| PRIMARY Progression Free Survival |
5.1; 1.8 | 0.001 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT05718466). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.