A Study of Neoadjuvant Stereotactic Radiosurgery for Large Brain Metastases (NASRS)
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|ClinicalTrials.gov Identifier: NCT03368625|
Recruitment Status : Recruiting
First Posted : December 11, 2017
Last Update Posted : April 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Brain Metastases||Radiation: Stereotactic Radiosurgery||Not Applicable|
Recently, a novel treatment strategy for large brain metastases was described whereby lesions appropriate for resection were treated with a single fraction of SRS pre-operatively. In a retrospective analysis, of 51 lesions with a median tumor size of 3 cm, 1-year LC was 86%. This neoadjuvant approach resulted in lower rates of leptomeningeal failure (3 vs. 17%) and symptomatic radiation toxicity (1.5 vs. 14.6 %) compared to a comparative cohort of lesions treated with post-operative cavity boost SRS (POCBS).
Based on promising results, we believe that a prospective trial to establish the value of neoadjuvant SRS (NaSRS) for the treatment of BM appropriate for resection is warranted.
This study will be a non-randomized phase II trial for patients with one to six brain metastases, at least one of which is appropriate for surgical resection. Upon registration, patients will be assigned to receive neo-adjuvant stereotactic radiosurgery (NASRS).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Patients with resectable brain mets will receive neoadjuvant stereotactic radiosurgery prior to surgical resection.|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Neoadjuvant Stereotactic Radiosurgery for Large Brain Metastases|
|Actual Study Start Date :||March 19, 2018|
|Estimated Primary Completion Date :||January 1, 2022|
|Estimated Study Completion Date :||January 1, 2022|
Radiation: Stereotactic Radiosurgery
Stereotactic Radiosurgery before surgical resection of brain mets.
- Radiation toxicity [ Time Frame: 1 year ]The rate at 1 year of symptomatic (≥grade 2) radiation toxicity
- local control [ Time Frame: 1 year ]1-year local control (PR+CR) of the index lesion resulting from NaSRS
- leptomeningeal disease [ Time Frame: 1 year ]1-year rates of leptomeningeal disease
- Survival [ Time Frame: 5 years ]Median survival
- progression-free survival [ Time Frame: 2 years ]
- overall survival [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03368625
|Contact: David Shultz, M.D.||416-946-4501 ext firstname.lastname@example.org|
|University Health Network||Recruiting|
|Toronto, Ontario, Canada, L4W4C2|
|Contact: David Shultz, MD|
|Principal Investigator:||David Shultz, MD||University Health Network, Toronto|