N/A
N=14
Mathematical Model-Adapted Radiation In Glioblastoma
Recurrent Glioblastoma
Bottom Line
View on ClinicalTrials.gov: NCT03557372 ↗Enrolled (actual)
14
Serious AEs
57.1%
Results posted
Jun 2021
Primary outcome: Primary: Number of Participants to Complete Model Adapted Radiations Fractionation Scheduled — 14 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mathematical Model-Adapted Radiation Fractionation Schedule (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dana-Farber Cancer Institute
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants to Complete Model Adapted Radiations Fractionation Scheduled |
14 | — |
| SECONDARY Number of Participants With Radiation Necrosis |
— | — |
| SECONDARY Number of Participants With Seizures |
1 | — |
| SECONDARY Overall Survival (OS) |
7.3 | — |
| SECONDARY Grade 3-5 Treatment-related Toxicity Rate |
0.29 | — |
| SECONDARY Median Progression-Free Survival (PFS) |
4.3 | — |
| SECONDARY Median Local Recurrence-free Survival |
6.2 | — |
| SECONDARY Number of Participants Undergoing Salvage Craniotomy |
— | — |
| SECONDARY Number of Participants Receiving Additional Systemic Treatments After Reirradiation |
3 | — |
Summary
This research study is studying a new schedule of radiation therapy for recurrent glioblastoma as a possible treatment for this diagnosis. This radiation schedule is based on a new model for radiation resistance in glioblastoma.
The name of the radiation schedule involved in this study is:
- Re-irradiation for glioblastoma using a novel Mathematical Model-Adapted Radiation Fractionation Schedule
Eligibility Criteria
Inclusion Criteria
- Participants must have recurrent glioblastoma (WHO Grade IV), as defined on brain imaging with CT or MRI, after prior receipt of definitive therapy including neurosurgical biopsy or resection and radiation therapy with or without systemic therapy.
- Participants must be deemed appropriate candidates for re-irradiation
- Histopathologic confirmation of disease as part of routine clinical care is required either at the time of initial diagnosis and/or at the time of recurrent disease. There is no requirement for central pathologic review.
- Age ≥ 18 years at the time of enrollment
- Karnofsky Performance Status (KPS) of at least 70
- Exclusion Criteria
- Participants who have received more than one prior course of radiotherapy to the local site of progressive disease
- Participants who have received prior radiotherapy to the local site of progressive disease within < 3 months of the anticipated start of re-irradiation
- Participants with recurrent tumor extensively abutting or involving the optic structures or brainstem, as assessed by the treating radiation oncologist
- Participants without a definable tumor cavity on MRI or CT obtained at study enrollment
- Participants receiving concurrent cytotoxic chemotherapy (i.e. temozolomide, CCNU, vincristine, procarbazine) or concurrent immunotherapy (i.e. pembrolizumab, nivolumab); however, participants may receive sequential chemotherapy before or after radiation without limitation. Participants may receive concurrent corticosteroid and/or anti-angiogenic therapy (i.e. bevacizumab) if clinically indicated.
Data sourced from ClinicalTrials.gov (NCT03557372). 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.