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Mathematical Model-Adapted Radiation In Glioblastoma
NA trial testing Mathematical Model-Adapted Radiation Fractionation Schedule in Recurrent Glioblastoma in 14 participants. Completed in 9 November 2022.
| Lead sponsor | Dana-Farber Cancer Institute |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 14 |
| Start date | 12 November 2018 |
| Primary completion | 9 November 2022 |
| Estimated completion | 9 November 2022 |
| Sites | 2 locations across United States |
Dana-Farber Cancer Institute
18 and older, any sex, with Recurrent Glioblastoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Successful completion of radiotherapy is defined as receipt of all scheduled fractions of daily radiotherapy within 24 hours of once daily fractions and within 1 hour of three-times daily fractions.
| Group | Value | 95% CI |
|---|---|---|
| Mathematical Model-Adapted Radiation | 14 |
Radiation necrosis (RN) was defined by clinical assessment including imaging features of an expansile, centrally hypointense lesion with increasing surrounding vasogenic edema and typically without features of high grade recurrence (restricted diffusion, elevated cerebral blood volume). Symptomatic RN included patients with radiographic RN requiring intervention such as corticosteroid therapy for neurologic symptoms, headaches, or signs of elevated intracranial pressure.
| Group | Value | 95% CI |
|---|---|---|
| Mathematical Model-Adapted Radiation | 0 |
Count of number of patients developing new/worsening seizures within 6 months of receiving protocol radiation therapy
| Group | Value | 95% CI |
|---|---|---|
| Mathematical Model-Adapted Radiation | 1 |
Overall Survival (OS) based on the Kaplan-Meier method is defined as the time from study entry to death or censored at date last known alive.
| Group | Value | 95% CI |
|---|---|---|
| Mathematical Model-Adapted Radiation | 7.3 | 4.7 – 10.7 |
All grade 3-5 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv5 as reported on case report forms were counted. Rate is the proportion of treated participants experiencing at least one treatment-related grade 3-5 AE of any type during the time of observation.
| Group | Value | 95% CI |
|---|---|---|
| Mathematical Model-Adapted Radiation | 0.29 |
Progression-free survival based on the Kaplan-Meier method is defined as the duration between randomization and documented disease progression (PD) (defined protocol section 12.7) or death, or is censored at time of last disease assessment.
| Group | Value | 95% CI |
|---|---|---|
| Mathematical Model-Adapted Radiation | 4.3 | 2.4 – 5.2 |
Local recurrence-free survival based on the Kaplan-Meier method is defined as the duration between randomization and documented Local recurrence or death, or is censored at time of last disease assessment.
| Group | Value | 95% CI |
|---|---|---|
| Mathematical Model-Adapted Radiation | 6.2 | 5.2 – 30 |
Count of patients undergoing salvage craniotomy for resection or decompression of progressively enlarging tumor within 6 months of receipt of protocol radiation therapy.
| Group | Value | 95% CI |
|---|---|---|
| Mathematical Model-Adapted Radiation | 0 |
Count of patients undergoing systemic therapies for presumed recurrence or progression of disease within 6 months after receipt of protocol radiation therapy
| Group | Value | 95% CI |
|---|---|---|
| Mathematical Model-Adapted Radiation | 3 |
Time frame: Time-frame for observation of adverse events was up to 6 months of clinical follow up, and for all cause-mortality, up to 38.6 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Mathematical Model-Adapted… |
|---|---|---|
| Death NOS | General disorders | — |
| Seizure | Nervous system disorders | — |
| Edema cerebral | Nervous system disorders | — |
| Hydrocephalus | Nervous system disorders | — |
| Reaction | System | Mathematical Model-Adapted… |
|---|---|---|
| Fatigue | General disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Infections and infestations - Other, specify | Infections and infestations | — |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | — |
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | — |
| Ataxia | Nervous system disorders | — |
| Edema cerebral | Nervous system disorders | — |
| Headache | Nervous system disorders | — |
Most-reported serious reactions: Death NOS, Seizure, Edema cerebral, Hydrocephalus.
Data from ClinicalTrials.gov NCT03557372 adverse events section.
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
6 peer-reviewed publications reference this trial (live from Europe PMC):
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