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Single Fraction Stereotactic Radiosurgery or Three to Five Fraction Stereotactic Radiosurgery in Treating Patients With Brain Metastasis That Has Been Removed by Surgery

StatusActive, Not Recruiting
PhasePhase 3
Started2019-11-19
View on ClinicalTrials.gov ↗

Amendment history

2026-07-21
Study Status v30
Primary completion moved earlier: 2026-09-01 → 2025-12-14
2026-04-20
Study Status v29
Primary completion pushed: 2026-03 → 2026-09-01
Completion pushed: 2028-03 → 2028-09
2026-01-23
Study Identification, Study Status, Oversight, Contacts/Locations v28
Study sitesdetails revised at 1 of 232 sites
Study titlerevised
Single Fraction Stereotactic Radiosurgery Compared withWith Fractionated Stereotactic Radiosurgery in Treating Patients withWith Resected Metastatic Brain Disease
2025-01-13
Study Identification, Study Status, Oversight, Contacts/Locations v27
Primary completion date2025-03→2026-03
Start date2019-10-11→2019-11-19
Study sitesdetails revised at 1 of 232 sites
Study titlerevised
Single Fraction Stereotactic Radiosurgery Compared Withwith Fractionated Stereotactic Radiosurgery in Treating Patients Withwith Resected Metastatic Brain Disease
2023-08-30
Study Status, Contacts/Locations v26
Study sites232 entries, revised
McFarland Clinic PC - Ames McFarland Clinic PC- Boone McFarland Clinic PC- Trinity Cancer Center McFarland Clinic PC- Jefferson McFarland Clinic PC- Marshalltown
Show 25 earlier versions
2023-03-16
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v25
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 208→confirmed 242
Study sites231→232
2022-04-18
Study Status, Contacts/Locations v24
Study sites229→231
2022-03-22
Study Status, Contacts/Locations v23
Study sites228→229
2022-02-16
Study Status, Contacts/Locations v22
Study sites220→228
2022-01-11
Study Status, Contacts/Locations v21
Study sites219→220
2021-12-13
Study Status, Contacts/Locations v20
Study sites217→219
2021-11-11
Study Status, Contacts/Locations v19
Study sites214→217
2021-11-01
Study Status, Study Description, Eligibility, Contacts/Locations v18
Study sites207→214
Eligibility criteria+65 characters
[...] brain metastasis must be located > 5 mm of the optic chiasm; andthe brain metastasis must be located outside the brainbrainstem stem(i.e. not inside the brainstem). Must not have any prior whole brain radiation therapy. Past [...]
Study description+128 characters
[...] patients who receive SSRS (Secondary QOL objective). X. To ascertainassess iffor timedifferences toin surgical bedCNS failure patterns (surgical, local, distant brain failure, leptomeningeal disease) as well as radiation necrosis rates as assessed by central review isin increasedpatients withwho receive FSRS compared to patients who receive SSRS inafter patientsresection withof resecteda brain metastasis. XI. To ascertain in patients with resecte [...]
2021-08-16
Study Status, Contacts/Locations v17
Study sites205→207
2021-07-19
Study Status, Contacts/Locations v16
Study sites201→205
2021-06-09
Study Status, Contacts/Locations v15
Study sites196→201
2021-04-16
Study Status, Contacts/Locations v14
Study sites194→196
2021-03-05
Study Status, Contacts/Locations v13
Study sites189→194
2021-02-05
Study Status, Contacts/Locations v12
Study sites185→189
2021-01-08
Study Status, Contacts/Locations v11
Study sites182→185
2020-12-08
Study Status, Contacts/Locations v10
Study sites181→182
2020-11-10
Study Status, Contacts/Locations v9
Study sites180→181
2020-10-08
Study Status, Contacts/Locations v8
Study sites168→180
2020-07-22
Study Status, Contacts/Locations v7
Study sites160→168
2020-06-03
Study Status, Contacts/Locations v6
Study sites154→160
2020-05-06
Study Status, Contacts/Locations v5
Study sites151→154
2020-04-09
Study Status, Contacts/Locations v4
Study sites130→151
2020-02-04
Study Status, Contacts/Locations v3
Study sites107→130
2019-11-19
Study Status, Contacts/Locations v2
Study sites6→107
2019-10-21
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2019-10→confirmed 2019-10-11
Study sites0→6
2019-10-02
Original filing
This phase III trial studies how well single fraction stereotactic radiosurgery works compared with fractionated stereotactic radiosurgery in treating patients with cancer that has spread to the brain from other parts of the body (brain metastases) and has been removed by surgery (resected). Single fraction stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Fractionated stereotactic radiosurgery delivers multiple, smaller doses of radiation therapy over time. This study may help doctors find out if fractionated stereotactic radiosurgery is better or worse than the usual approach with single fraction stereotactic radiosurgery.
Trial Details
NCT Number NCT04114981
Lead Sponsor Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI)
Conditions Metastatic Malignant Neoplasm in the Brain
Enrollment 242 participants
Start Date 2019-11-19
Primary Completion 2025-12-14 (estimated)
Study Completion 2028-09 (estimated)
Updated on ClinicalTrials.gov 2026-09-17