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Stereotactic Radiosurgery or Whole Brain Radiation Therapy in Treating Patients With Newly Diagnosed Non-melanoma Brain Metastases

StatusActive, Not Recruiting
PhasePhase 3
Started2012-08-02
View on ClinicalTrials.gov ↗

Amendment history

2026-03-05
Study Identification, Study Status v32
Re-verified, no change to tracked fields
2025-09-11
Study Status v31
Primary completion date2025-09-30→2027-09-30
Completion date2025-09-30→2027-09-30
2025-08-12
4 amendments v27-v30
4 re-verifications since 2024-02-16, no change to tracked fields
2023-08-16
Study Status, References v26
Primary completion date2023-09→2025-09-30
Completion date2023-09→2025-09-30
2023-02-24
Study Status v25
Primary completion date2022-09→2023-09
Show 24 earlier versions
2022-08-18
Study Status v24
Re-verified, no change to tracked fields
2021-09-22
Study Status, Study Design v23
Primary completion date2021-09→2022-09
Completion date2021-09→2023-09
Enrollment target74→88
2021-08-25
Recruiting→Active, Not Recruiting Study Identification, Study Status, Study Design, Contacts/Locations v22
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2020-08-31→2021-09
Completion date2020-08-31→2021-09
Enrollment targetestimated 100→confirmed 74
Study sitesdetails revised at 1 of 1 site
2019-12-27
Study Status, Oversight, Eligibility v21
Primary completion date2019-08-31→2020-08-31
Completion datenot stated→2020-08-31
Eligibility criteria+13 characters
Inclusion Criteria: All patients must have histological proof of malignant cancer, which is metastatic; histological. Histological proof may be obtained from the primary tumor or another metastatic site; however. However, cytology alone is not an acceptable method of diagnosis. All patients must have greater than 3 but less than or equal to 15 metastatic lesions seen on a contrast enhancing magnetic resonance imaging (MRI) scan obtained not less than one month prior to study enrollment; patients. Patients who are found to have up to 20 metastatic lesions at the ti [...] e head frame is in place) may [...]
2019-05-31
Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Description, Conditions, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v20
Primary completion date2019-08→2019-08-31
Completion date2020-08→not stated
InterventionsCognitive Function Tests (Behavioral), Questionnaires (Behavioral), Stereotactic Radiosurgery (SRS) (Radiation), Whole Brain Radiation…→Cognitive Assessment (Other), Quality-of-Life Assessment (Other), Stereotactic Radiosurgery (Radiation), Whole-Brain Radiotherapy…
Eligibility criteria-13 characters
Inclusion Criteria: All patients must have histological proof of malignant cancer, which is metastatic. Histological; histological proof may be obtained from the primary tumor or another metastatic site. However; however, cytology alone is not an acceptable method of diagnosis. All patients must have greater than 3 but less than or equal to 15 metastatic lesions seen on a contrast enhancing magnetic resonance imaging (MRI) scan obtained not less than one month prior to study enrollment. Patients; patients who are found to have up to 20 metastatic lesions at the ti [...] e head frame is in place) may [...]
Secondary endpoints+137 characters
Time to local failure Cumulative incidence of local failure Time to neurocognitive decline Cumulative incidence of neurocognitive decline
Primary endpoints2 entries, revised
Cognitive Decline Local Tumorcontrol Controlrate Proportion of patients with neurocognitive decline
Study description-177 characters
StudyPRIMARY GroupsOBJECTIVES: IfI. youTo arecompare foundlocal tumor control 4 months after treatment of patients with 4 to be15 eligibleintracranial tonon-melanoma takemetastases part in this study, you will be randomly assigned (as inat the fliptime of aenrollment coin)(=< to15 1at time of 2treatment) studytreated groups. You will have an equal chance of being assigned to either group: If you are in Group 1, you will receive whole brain radiation treatment. If you are in Group 2, you will receive stereotactic radiosurgery. Study Procedures: If you are in Group 1, you will receive whole brai [...] [...]
Study sites1 entry, revised
UniversityM of Texas MDD Anderson Cancer Center
Collaborators+31 characters
National Cancer Institute (NCI)
Study title+27 characters
A Prospective Phase III Trial to Compare Stereotactic Radiosurgery Versusor Whole Brain Radiation Therapy in Treating Patients With Newly Diagnosed Non-melanoma Brain Metastases
2019-05-15
Study Status, Contacts/Locations v19
Completion date2019-08→2020-08
2019-01-10
Study Status v18
Re-verified, no change to tracked fields
2018-01-09
Study Status, Study Description v17
Study description-272 characters
[...] u may still continue to participate in the study with up to 1520 tumors. If there are more than 1520 tumors found on the treatment planning MRI scan on the day [...] ng. You will have an MRI to check the status of the disease. This is an investigational study. It is considered investigational to compare stereotactic radiosurgery to whole brain radiation therapy in patients with 4-10 non-melanoma brain tumors. Up to 100 patients will take part in this study. All will be enrolled at MD Anderson.
2017-07-12
Study Status, Oversight, Eligibility v16
Eligibility criteria+6 characters
[...] patients must have greater than 3 but less than or equal to 1015 metastatic lesions seen on a contrast enhancing MRI scan ob [...] h prior to study enrollment. Patients who are found to have 11-15up to 20 metastatic lesions at the time of treatment planning (on vo [...] n. Patients will be excluded if they have < 4 lesions, or > 1015 lesions at enrollment or > 1520 lesions at the time of treatment (note: patients who qualify for enrollment based on having 4-1015 lesions, but who are discovered to have 11-15up to 20 lesions on the volumetric MRI used for treatment planning will be allowed to continue on stud [...]
2017-06-29
Active, Not Recruiting→Recruiting Study Status, Study Design, Contacts/Locations v15
Trial statusActive, Not Recruiting→Recruiting
Enrollment target54→100
Study sitesdetails revised at 1 of 1 site
2017-06-13
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v14
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2018-08→2019-08
Completion datenot stated→2019-08
Start date2012-08→2012-08-02
Enrollment targetestimated 100→confirmed 54
Study sitesdetails revised at 1 of 1 site
2017-01-10
Study Status v13
Re-verified, no change to tracked fields
2016-07-08
Study Status v12
Primary completion date2017-08→2018-08
2015-12-28
Study Status v11
Re-verified, no change to tracked fields
2015-06-25
Study Status v10
Primary completion date2016-08→2017-08
2014-12-15
Study Status, Eligibility v9
Eligibility criteria+120 characters
[...] l disease. Patients will be excluded if they have had prior radiationWhole toBrain the brainRadiotherapy (eitherWBRT) WBRT,or prophylactic cranial irradiation (PCI),. Prior SRS or SRSGamma Knife radiosurgery to 1-3 metastases with minimum of (6) weeks to the most recent scan are allowed on protocol. Female patients of childbearing age will be excluded if th [...]
2014-08-21
Study Status, Contacts/Locations, References v8
Study sites1 entry, revised
UTUniversity of Texas MD AndresonAnderson Cancer Center
2014-02-20
Study Identification, Study Status v7
Re-verified, no change to tracked fields
2013-11-06
Study Status, Arms and Interventions, Outcome Measures, Eligibility, References v6
Eligibility criteria-83 characters
[...] um diameter of largest lesion < 3.5cm) as determined by the study radiation oncologist . All patients must have adequate liver [...] ior surgical resection of metastatic cancer from the brain. Patients will be excluded if there are one or more lesions in the brainstem. Patients will be excluded if there is radiographic or CSF cy [...]
2013-08-09
Study Status, Contacts/Locations v5
Re-verified, no change to tracked fields
2013-06-07
Study Status, Eligibility v4
Eligibility criteria-154 characters
[...] equal to 10 metastatic lesions seen on a contrast enhancing magnetic resonance imaging (MRI) scan obtained not less than one month prior to study enroll [...] st have been approved and amended by the M.D. Anderson IRB. All patients must have a baseline neurocognitive function (HVLT-R) >/=17. All patients must have a Karnofsky Performance Score (KPS) >/= 70. All patients must be eligible to have all lesions treated with stereotactic radiosurgery (SRS) (i.e. maximum diameter of largest lesion < 3.5cm) as determ [...] rs after radiosurgery has concluded. Those patients getting whole brain radiation therapy (WB [...] [...]
2013-05-09
2 amendments v2-v3
2 re-verifications since 2013-02-04, no change to tracked fields
2012-08-02
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2016-10→2016-08
Start date2012-10→2012-08
Study sitesdetails revised at 1 of 1 site
2012-05-04
Original filing
This randomized phase III clinical trial compares stereotactic radiosurgery with whole brain radiation therapy to see how well they work in treating patients with non-melanoma cancer that has recently spread from the first location to the brain. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Stereotactic radiosurgery is a specialized type of radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Whole brain radiation therapy delivers a lower dose of radiation to the entire brain over several treatments. It is not yet known whether stereotactic radiosurgery works better than whole brain radiation therapy in treating patients with non-melanoma brain metastases. Stereotactic radiosurgery may also cause fewer thinking and memory problems than whole brain radiation therapy.
Trial Details
NCT Number NCT01592968
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)
Conditions Metastatic Malignant Neoplasm, Metastatic Malignant Neoplasm in the Brain
Enrollment 88 participants
Start Date 2012-08-02
Primary Completion 2027-09-30 (estimated)
Study Completion 2027-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-16