Preoperative vs Postoperative Hypofractionated Radiosurgery for Patients With Large Brain Metastases
NCT05545007, Not applicable, Recruiting, Istituto Clinico Humanitas
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Preoperative vs Postoperative Hypofractionated Radiosurgery for Patients With Large Brain Metastases | ClinicalTrials.gov |
| NCT number | NCT05545007 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 146 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Istituto Clinico Humanitas | ClinicalTrials.gov |
| Conditions | Brain Metastases, Adult | ClinicalTrials.gov |
| Interventions | Hypofractionated Radiosurgery (HSRS), Brain metastases surgical resection | ClinicalTrials.gov |
| First posted | 2022-09-19 | ClinicalTrials.gov |
| Last updated | 2026-04-30 | ClinicalTrials.gov |
Registered outcomes 7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Rate of LMD (leptomeningeal disease) occurrence | 1 year | Rate of LMD occurrence in patients who receive HSRS prior to surgery as compared to patients who receive HSRS after surgery. This assessment will be evaluated through radiological images. | ClinicalTrials.gov |
| Secondary | Rate of local recurrence | 1 year | To evaluate for patients undergone pre-operative as compared to post-operative HSRS whether there is a decreased rate of local recurrence. This assessment will be evaluated through radiological images. | ClinicalTrials.gov |
| Secondary | Rate of brain distant progression | 1 year | To evaluate for patients undergone pre-operative as compared to post-operative HSRS whether there is a decreased rate of brain distant progression. This assessment will be evaluated through radiological images. | ClinicalTrials.gov |
| Secondary | Overall Survival | 1 year | To evaluate for patients with brain metastases whether there is improved overall survival for patients who receive HSRS prior to surgery as compared to patients who receive HSRS after surgery. | ClinicalTrials.gov |
| Secondary | Radiation Necrosis Evaluation | 1 year | To evaluate for patients undergone pre-operative as compared to post-operative HSRS whether there is a decreased rate of symptomatic radiation necrosis (RN). RN will be evaluated through radiological images. | ClinicalTrials.gov |
| Secondary | Rate of surgical Morbidity | 1 year | To evaluate whether preoperative SRS increases rates of surgical morbidity including postoperative complications such as wound infection, need for longer hospital stays, readmission and eventual delay of systemic treatments | ClinicalTrials.gov |
| Secondary | Quality of Life and neurocognitive functions evaluation | 1 year | To evaluate quality of life (EORTC QLQ-C30, version 3.0) and neurocognitive functions throught specific questionnaires administered to patients. Neurocognitive test: * Token Test (Spinnler e Tognoni, 1987) * Picture naming of objects (Catricalà 2012) and of actions (Papagno et al., 2020) * Verbal fluency on phonemic and semantic cue (Novelli et al., 1986) * Rey's 15 words auditory learning test (Carlesimo et al.,1996) * Reproduction of the Rey figure (Caffarra et al., 2002) * Stroop test (Caffarra et al. 2002) * Trail making test (Giovagnoli et al. 1996) * Copy of Rey Figure (Cafarra et al., 2002) | 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 6
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 |
|---|---|---|
| Picture Naming Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Token Commands Task | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
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)