A Phase-1 Trial to Investigate the Use of Pulsed Low-dose Rate Radiotherapy in Diffuse Midline Gliomas.
NCT07918105, Not applicable, Recruiting, Centro di Riferimento Oncologico - Aviano
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Phase-1 Trial to Investigate the Use of Pulsed Low-dose Rate Radiotherapy in Diffuse Midline Gliomas. | ClinicalTrials.gov |
| NCT number | NCT07918105 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 12 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Centro di Riferimento Oncologico - Aviano | ClinicalTrials.gov |
| Conditions | Diffuse Midline Glioma | ClinicalTrials.gov |
| Interventions | Pulsed Low-Dose-Rate Radiotherapy, pLDRT | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-05 | ClinicalTrials.gov |
Registered outcomes 11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Determination of the safe dose level of pulsed low-dose-rate radiotherapy (pLDRT) | Up to 5 years | Incidence of grade ≥3 toxicities, as defined according to the CTCAE v5.0 scale | ClinicalTrials.gov |
| Secondary | To evaluate the median time to local disease progression. | Up to 5 years | Median progression-free survival (PFS) defined as the time from treatment initiation to the first documented disease progression or death from any cause. Disease progression will be defined according to the RAPNO criteria for pediatric patients and the RANO criteria for adult patients. | ClinicalTrials.gov |
| Secondary | To evaluate median overall survival. | Up to 5 years | Median overall survival (OS), defined as the time from treatment initiation to death from any cause. | ClinicalTrials.gov |
| Secondary | To assess the incidence of treatment-related toxicities other than dose-limiting toxicities. | Up to 5 years | Frequency of neurological toxicities | ClinicalTrials.gov |
| Secondary | To assess changes in neurological symptoms compared with baseline. | Up to 5 years | Change in frequencies of neurological symptoms | ClinicalTrials.gov |
| Secondary | To evaluate corticosteroid use during radiotherapy. | Up to 5 years | Dexamethasone dose (mg/day) mean | ClinicalTrials.gov |
| Secondary | To evaluate circulating prognostic and predictive biomarkers of response to pLDRT. | Up to 5 years | Relation between PFS (defined as the time from treatment initiation to the first documented disease progression or death from any cause) and levels of circulating biomarkers will be evaluated with Kaplan-Meyer method | ClinicalTrials.gov |
| Secondary | To evaluate circulating prognostic and predictive biomarkers of response to pLDRT. | Up to 5 years | Relation between OS (defined as the time from treatment initiation to death from any cause) and levels of circulating biomarkers will be evaluated with Kaplan-Meyer method | ClinicalTrials.gov |
| Secondary | To evaluate tissue biomarkers of response to pLDRT. | Up to 5 years | Relation between PFS (defined as the time from treatment initiation to the first documented disease progression or death from any cause) and levels of tissue biomarkers will be evaluated with Kaplan-Meyer method | ClinicalTrials.gov |
| Secondary | To evaluate tissue biomarkers of response to pLDRT. | Up to 5 years | Relation between OS (defined as the time from treatment initiation to death from any cause) and levels of tissue biomarkers will be evaluated with Kaplan-Meyer method | ClinicalTrials.gov |
| Secondary | To characterize the inflammatory and immune profile induced by the pLDRT treatment schedule. | Up to 5 years | Mean of median levels of biomarkers of inflammatory and immune profile | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)