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Pre-operative SRS or Post-operative SRS in Treating Cancer Patients With Brain Metastases

StatusActive, Not Recruiting
PhasePhase 3
Started2018-11-08
View on ClinicalTrials.gov ↗

Amendment history

2026-08-05
Study Status, Study Design, Contacts/Locations v12
Enrollment closed, study ongoing
Study sitesdetails revised at 1 of 1 site
2025-09-04
Study Status v11
Re-verified, no change to tracked fields
2025-03-11
Study Status, Study Design, Document Section v10
Enrollment target110→180
2024-08-19
Study Status v9
Primary completion date2024-07-10→2027-01-31
Completion date2024-07-10→2027-01-31
2024-02-15
3 amendments v6-v8
3 re-verifications since 2023-01-18, no change to tracked fields
Show 5 earlier versions
2023-01-18
Study Status v5
Primary completion date2022-07-10→2024-07-10
Completion date2022-07-10→2024-07-10
2022-06-09
Study Identification, Study Status, Study Design, References v4
Enrollment target86→110
2020-03-06
Study Status v3
Re-verified, no change to tracked fields
2019-12-26
Study Status, Study Description, Outcome Measures v2
Study description-2 characters
PRIMARY OBJECTIVESOBJECTIVE: I. To investigate the 1 year leptomeningeal disease (LMD)- [...] ative SRS followed by surgery (experimental arm). SECONDARY OBJECTIVESOBJECTIVE: I. To investigate the local control (LC), distant brain me [...]
2019-07-31
Study Status, Study Description, Outcome Measures, Eligibility, Contacts/Locations v1
Eligibility criteria-223 characters
Inclusion Criteria: The primary posterior fossa lesion pre-operatively or the post-operative resection cavity mustcan have a maximum diameter of =< 4 cm for single fraction and =< 87 cm for multifraction (will be determined by the study radiologist)therapy Additional unresected brain metastases must have a maximum diameter of =< 4 cm for single fraction and =< 8 cm for multifraction Patients must be considered candidates for SRS within +/- 30 [...]
Secondary endpoints9 to 3 entries
Neurocognitive function measured by neurocognitive decline on Hopkins Verbal Learning Test-Revised (HVLT-R) Symptom burden Health outcomes Neurocognitive function measured by controlled Oral Word Association (COWA) Neurocognitive function measured by Trail Making Test (TMT) parts A and B Neurocognit [...]
Study description-124 characters
[...] l (LC), distant brain metastasis rate, overall survival (OS) and neuro-cognitive impact of pre-operative (pre-op) versus (vs) post-operative (post-op) SRS in patients with brain metastasis. This aim includes an evaluation of the impact of the method used for stereotactic radiosurgery including, Gamma Knife single fraction, Gamma Knife fractionated with ICON, or LINAC (linear accelerator) based fractionated SRS, as well as an assessment on the impact of tumor volume and cavity volume. EXPLORATORY OBJECTIVES: I. To assess the reliability of diff [...] oxygenation and presence of inflammation/immune rea [...]
Study sitescontacts updated at 1 of 1 site
2018-11-14
Original filing
This phase III trial studies stereotactic radiosurgery (SRS) before surgery to see how well it works compared with SRS after surgery in treating patients with cancer that has spread to the brain (brain metastases). SRS is the delivery of focused, high-dose radiation given in a single session to the tumors, with a minimal dose given to uninvolved areas of the brain.
Trial Details
NCT Number NCT03741673
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)
Conditions Malignant Neoplasm, Metastatic Malignant Neoplasm in the Brain
Enrollment 180 participants
Start Date 2018-11-08
Primary Completion 2027-01-31 (estimated)
Study Completion 2027-01-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-10