2023-08-25
minor
Study Status, Contacts/Locations v25
Re-verified, no change to tracked fields
Show 24 earlier versions
2023-02-24
minor
Study Status v24
Primary completion date2020-08-31→2023-08-31
Completion date2020-08-31→2023-08-31
2019-12-27
minor
Study Status, Oversight, Eligibility v23
Primary completion date2019-08-31→2020-08-31
Eligibility criteria+96 characters
Inclusion Criteria:
Patients must be older than 3 years of age (radiosurgical frames cannot be placed on children younger than age 3).
Patients must have 3 or fewer newly diagnosed metastatic les [...] h a complete resection of at least one lesion as determined by the study neuroradiologist.
The resection cavity must have a maximum diameter of less than or equal to 4 cm; this4cm.
This criteria will be determined by the study radiologist).
Additional unresected brain metastases (up to 2) must have a maximum diameter of less than or equal to 3 cm.
Patients must be considered candidates for SRS within 3 [...] [...]
2019-05-29
minor
Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Description, Conditions, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v22
Primary completion date2019-08→2019-08-31
Completion date2020-08→2020-08-31
Start date2009-08→2009-08-13
InterventionsMRI (Procedure), Stereotactic Radiosurgery (SRS) (Procedure)→Stereotactic Radiosurgery (Radiation)
Eligibility criteria-96 characters
Inclusion Criteria:
Patients must be older than 3 years of age (radiosurgical frames cannot be placed on children younger than age 3).
Patients must have 3 or fewer newly diagnosed metastatic les [...] h a complete resection of at least one lesion as determined by the study neuroradiologist.
The resection cavity must have a maximum diameter of less than or equal to 4cm.
This4 cm; this criteria will be determined by the study radiologist.)
Additional unresected brain metastases (up to 2) must have a maximum diameter of less than or equal to 3 cm.
Patients must be considered candidates for SRS within 3 [...] [...]
Secondary endpoints+278 characters
Overall survival
Development of distant brain metastases
Incidence of complications related to treatment
Proportion of patients experiencing neurological complications
Proportion of complications resulting in prolongation of hospital stay
Time to first neurological complication
Primary endpoints1 entry, revised
Time to Locallocal Recurrence (TTLR)recurrence
Study description-2,382 characters
AfterPRIMARY surgeryOBJECTIVES:
I. toTo removeevaluate brain metastasis, patients are usually given whole brain radiotherapy becausebenefit of post-surgical stereotactic radiosurgery (SRS) on the resection bed in providing 6 month local control (decreasing the risk of thelocal tumor regrowingrecurrence) inwhen thatcompared areato orsurgical inresection other places in the brainalone.
ItSECONDARY isOBJECTIVES:
I. givenOverall insurvival, 10-14 daily sessions over 2-3 weeks.
Becausedevelopment of thedistant potentialbrain sidemetastases effectsand complications related to treatment.
OUTLINE: Pat [...] [...]
Study sites1 entry, revised
UniversityM of Texas MDD Anderson Cancer Center
Collaborators+31 characters
National Cancer Institute (NCI)
Study title+33 characters
Resection Bed Post-Surgical Stereotactic Radiosurgery (SRS)Compared to Observation in Treating Patients With Brain Metastases
2018-02-26
minor
Study Status, Oversight v21
Completion date2019-08→2020-08
2017-08-01
minor
Study Status, Contacts/Locations v20
Primary completion date2018-08→2019-08
Completion date2018-08→2019-08
2017-02-20
minor
Study Status v19
Primary completion date2017-08→2018-08
Completion datenot stated→2018-08
2016-02-17
notable
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v18
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 1 of 1 site
2016-01-14
minor
Study Status, Outcome Measures v17
Re-verified, no change to tracked fields
2015-07-14
minor
Study Status, Outcome Measures v16
Primary completion date2016-08→2017-08
2015-01-12
minor
Study Status, Study Design, Contacts/Locations v15
Study sites1 entry, revised
UTUniversity of Texas MD Anderson Cancer Center
2014-07-11
minor
Study Status, References v14
Re-verified, no change to tracked fields
2014-02-20
minor
Study Identification, Study Status, Study Description, Arms and Interventions v13
Primary completion date2015-08→2016-08
Study description+1 characters
[...] if whole brain radiotherapy is used.
Additional Information:
If an MRI scan indicates that the tumor has returned or a ne [...]
2013-09-30
minor
Study Status, Study Description v12
Primary completion date2014-08→2015-08
Study description+296 characters
[...] gery, at 5-8 weeks after surgery, every 6-9 weeks for a year, and then every 3-4 months for a year, then every 6 months after that.
At these times, the area of surgery and any othe [...] to the surgery site or if whole brain radiotherapy is used.
Additional Information If an MRI scan indicates that the tumor has returned or a new lesion has occurred in the brain, you and your doctor will discuss other treatment options including surgery, stereotactic radiosurgery, whole brain radiotherapy, or chemotherapy.
This is an investigational study.
Stereotactic radiosurgery [...]
2013-05-02
minor
2 amendments v10-v11
2 re-verifications since 2012-11-01, no change to tracked fields
2012-07-19
minor
Study Status, Arms and Interventions, Eligibility v9
Eligibility criteria-67 characters
[...] ty must have a maximum diameter of less than or equal to 4cm at the time of the post operative magnetic resonance imaging (MRI).
This criteria will be determined by the study radiologist. [...]
2012-02-17
minor
Study Status, Study Description v8
Study description-269 characters
[...] to the surgery site or if whole brain radiotherapy is used.
Additional Information:
If an MRI scan indicates that the tumor has returned or a new lesion has occurred in the brain, you and your doctor will discuss other treatment options including surgery, stereotactic radiosurgery, whole brain radiotherapy, or chemotherapy.
This is an investigational study.
Stereotactic radiosurgery [...] ients will take part in this study.
All will be enrolled at M. D.MD Anderson.
2011-11-04
minor
4 amendments v4-v7
4 re-verifications since 2010-09-16, no change to tracked fields
2010-03-31
minor
Study Status, Study Description, Eligibility v3
Eligibility criteria-104 characters
[...] mia, or multiple myeloma.
For females, if they are pregnant (determined with a serum beta human chorionic gonadotrophin (b-HCG) at the time of surgical resection) or breast-feeding.
(The exclusion is made because gadolinium may be teratogenic in pregnancy).
Study descriptionrevised
[...] ll have standard MRI scans of the brain after surgery, at 5-78 weeks after surgery, every 6-9 weeks for a year, and then e [...]
2009-08-14
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2009-08-13
minor
Study Status, Contacts/Locations v1
Re-verified, no change to tracked fields