2026-09-30
critical
Primary endpoint(s) modified1 entry, revised
WasQuality of Life Survey (symptoms and interference)
NowChange in MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT) Score
Sponsor changed: Dana-Farber Cancer Institute → Brigham and Women's Hospitalrevised
WasDana-Farber Cancer Institute
NowBrigham and Women's Hospital
Completion pushed: 2025-09-30 → 2027-09-30
Results posted: 2026-09-29
2026-07-30
minor
Study Status, Outcome Measures, Baseline Characteristics, Outcome Measures (Results) v14
Secondary endpoints31 entries, revised
Karnofsky Performance Status Compliance
Mini-Mental State Examination Z Score at Baseline
2026-06-16
minor
Study Status, Outcome Measures, Baseline Characteristics, Outcome Measures (Results), Adverse Events v13
Secondary endpoints47 to 31 entries
12 Month Cumulative Incidence and Time toof Neurologic Death
12 Month Cumulative Incidence and Time to Detection of New Brain Metastases
12 Month Cumulative Incidence and Time toof Local Recurrence of Treated Brain Tumor(s)
12 Month Cumulative Incidence andof Time toProgressive Intracranial Disease
12 Month Cumulative Incidence and Time toof Radiographic Radiation Necrosis
12 Month Cumulative Incidence and Time to Development of Leptomeningeal Disease
12 Month Cumulative Incidence and Time toof Dexamethasone Initiation
12 Month Cumulative Incidence and Time to theof Development of Seizures
12 [...] [...]
Primary endpoints1 entry, revised
QualityChange ofin LifeMD SurveyAnderson Symptom Inventory - Brain Tumor (SymptomsMDASI-BT) and Interference)Score
2026-03-23
minor
Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Design, Outcome Measures, References, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events v12
Completion date2025-09-30→2027-09-30
Lead sponsorDana-Farber Cancer Institute→Brigham and Women's Hospital
Secondary endpoints11 to 47 entries
Overall survival
Neurologic survivalSurvival
Incidence and timeTime to detectionNeurologic of new brain metastasesDeath
Incidence and timeTime to local recurrenceDetection of treatedNew brainBrain tumorMetastases
Incidence and Time to Local Recurrence of Treated Brain Tumor(s)
Incidence and timeTime to developmentIntracranial of radiation necrosisDisease
Incidence and timeTime to developmentRadiographic ofRadiation leptomeningeal diseaseNecrosis
Incidence and timeTime to salvageDevelopment craniotomyof Leptomeningeal Disease
Incidence and timeTime to additionalDexamethasone radiotherapeutic tr [...] [...]
Primary endpoints1 entry, revised
Quality of Life Survey (symptomsSymptoms and interferenceInterference)
Collaborators1 entry, revised
BrighamDana-Farber andCancer Women's HospitalInstitute
Publications1 to 4 entries
Ayal Aizer et al. Stereotactic radiation versus hippocampal avoidance whole brain radiation in patients with 5-20 brain metastases: A multicenter, phase 3 randomized trial.. J Clin Oncol 43, 2011-2011(2025). DOI:10.1200/JCO.2025.43.16_suppl.2011
Aizer A et al. Multicenter, Phase 3 Randomized Trial o [...]
2024-10-22
notable
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v11
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2024-09-30→2024-11-07
Study sitesdetails revised at 2 of 2 sites
Show 10 earlier versions
2023-09-21
minor
Study Status, Study Design, Contacts/Locations v10
PhasePhase 3→Not applicable
Primary completion date2023-07-30→2024-09-30
Completion date2024-07-30→2025-09-30
2022-07-18
minor
Study Status v9
Re-verified, no change to tracked fields
2021-05-18
minor
Study Status, Sponsor/Collaborators v8
Primary completion date2022-07-30→2023-07-30
Completion date2023-07-30→2024-07-30
2020-12-22
minor
Study Identification, Study Status, Outcome Measures, Eligibility v7
Primary completion date2021-03-30→2022-07-30
Completion date2022-03-30→2023-07-30
Eligibility criteria-1 characters
[...] who have undergone prior systemic therapy are eligible
Five-fifteentwenty intracranial lesions must be present on MRI of the brain
Ag [...]
Primary endpoints1 entry, revised
Quality of Life Survey (symptoms and interference)
Study title+5 characters
Hippocampal Sparing Whole Brain Radiation Versus Stereotactic Radiation (SRS) in Patients With 5-20 Brain Metastases: A Phase III, Randomized Clinical Trial
2020-02-06
minor
Study Status v6
Re-verified, no change to tracked fields
2019-01-22
minor
Study Status, Oversight, Contacts/Locations v5
Study sitescontacts updated at 1 of 2 sites
2017-12-20
minor
Study Status, Outcome Measures v4
Secondary endpointsdetails revised at 1 of 11 entries
2017-11-21
minor
Study Identification, Study Status, Study Description, Arms and Interventions, Eligibility v3
Eligibility criteria-17 characters
[...] brain metastases
Karnofsky performance status of at least 70 (See Appendix A)
Exclusion Criteria:
Participants who have undergone prior r [...]
Study descriptionrevised
[...] brain radiation is the standard option for patients with 5-1520 brain metastases.
Stereotactic radiation is the standard op [...] actic radiation improves quality of life in patients with 5-1520 brain metastases relative to whole brain radiation.
In this [...] in a better subsequent quality of life for patients with 5-1520 brain metastases.
Study titlerevised
Whole Brain Radiation Versus Stereotactic Radiation (SRS) in Patients With 5-1520 Brain Metastases: A Phase III, Randomized Clinical Trial
2017-04-19
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2017-03-30→confirmed 2017-04-10
Study sites1→2
2017-03-08
minor
Study Status, Outcome Measures v1
Secondary endpointsdetails revised at 3 of 11 entries
2017-03-04
minor
Original filing