Post-Surgical Stereotactic Radiotherapy (SRT) Versus GammaTile
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|ClinicalTrials.gov Identifier: NCT04365374|
Recruitment Status : Recruiting
First Posted : April 28, 2020
Last Update Posted : July 20, 2021
|Condition or disease||Intervention/treatment||Phase|
|Brain Metastases||Device: Gamma Tile-Surgically Targeted Radiation Therapy (STaRT) Radiation: Stereotactic Radiation Therapy||Phase 3|
GammaTile therapy results in improved clinical outcomes; however the data is a single site experience with a limited number of subjects, only 12 of which were patients with metastatic brain tumors. The primary objective of this randomized, controlled trial is to compare the efficacy and safety of intraoperative radiation therapy using GammaTilesTM (GT) versus SRS 3-4 weeks following metastatic tumor resection which is the current standard of care. The data collected in this trial design will allow for a direct comparisons of a variety of outcomes including local control, overall survival, functional status, quality of life, neurocognitive status and safety in the target population. In order to support direct comparisons, subjects will be randomized to the two equally sized arms (1:1) based on the following stratification factors; age (<60 and ≥60), duration of extracranial disease control (≤3 months vs >3 months), number of metastases (one or two to four), histology (lung and radiation resistant), and the maximal diameter of the index lesion (≤3 cm and >3 cm).
An index lesion meeting the criteria of 2.5cm to 5cm in diameter and appropriate for gross total resection (GTR), will be identified and up to three other non-resectable lesions in a patient will be allowed. After resection of the index lesion the surgical bed will be treated with adjunct radiation (either GT or SRS) thereby following the standard of care guideline. (NCCN Guidelines, 2019). Additional unresected metastatic lesions will be treated with with stereotactic radiosurgery alone, which also adhears to standard of care guidelines.(NCCN Guidelines, 2019).
GammaTile is an FDA-cleared means of rapid dose delivery of radiation therapy directly to the tumor bed with predictable dosimetry at the immediate time of re-resection, and a intense but localized radiation treatment may confer a reduced risk for radiation necrosis compared to other therapies. It is typically easly placed with minimal additional operative time and limited staff radiation exposure.
Given these benefits, the rationale for conducting this randomized control comparison study is to generate additional data, to further support the use of this new FDA-cleared method of delivering radiation therapy in the setting of newly diagnosed brain metastases.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Phase 3 Randomized Controlled Trial of Post-Surgical Stereotactic Radiotherapy (SRT) Versus Surgically Targeted Radiation Therapy (STaRT) With Gamma Tile for Treatment of Newly Diagnosed Metastatic Brain Tumors.|
|Actual Study Start Date :||April 6, 2021|
|Estimated Primary Completion Date :||December 30, 2025|
|Estimated Study Completion Date :||December 30, 2027|
Experimental: Surgical Resection and GammaTile Therapy
Surgical Resection and GammaTile Therapy
Device: Gamma Tile-Surgically Targeted Radiation Therapy (STaRT)
GammaTiles are a permanently implanted radiation device consisting of Cs-131 seeds positioned within a collagen tile
Other Name: Carrier Tile Brachytherapy Therapy (CTBT)
Active Comparator: Surgical Resection and Stereotactic Radiation Therapy
Surgical Resection and Stereotactic Radiation Therapy
Radiation: Stereotactic Radiation Therapy
External Beam Radiation Therapy
- Surgical bed recurrence-free survival (SB-RFS) from the time of randomization up to 2 years post radiation. [ Time Frame: up to 2 years post-radiation ]Surgical bed control is defined as the absence of new nodular contrast enhancement in the index lesion surgical bed.
- Overall Survival [ Time Frame: up to 3 years ]Survival of subjects
- Functional Assessment of Cancer Therapy-Brain (FACT-Br) [ Time Frame: up to 9 months ]An assessment of quality of life (QOL)
- Linear Analog Scale Assessments (LASA) [ Time Frame: up to 9 months ]An assessment of quality of life (QOL)
- Hopkins Verbal Learning Test (HVLT-R) [ Time Frame: up to 24 months ]An assessment of neurocognitive status
- Controlled Oral Word Association Test (COWAT) [ Time Frame: up to 24 months ]An assessment of neurocognitive status
- Trail Making Tests (TMT) Parts A and B [ Time Frame: up to 24 months ]An assessment of neurocognitive status
- Barthel ADL [ Time Frame: up to 24 months ]An assessment of physical functioning status
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): NCT04365374
|Contact: Lisa Misell GT Medical Technologies, PhD||(833) email@example.com|
|Contact: Angela Hall GT Medical Technologies, PTfirstname.lastname@example.org|
|United States, Georgia|
|Atlanta, Georgia, United States, 30309|
|Contact: Adam Nowlan, MD,MPH 404-425-7900 email@example.com|
|United States, Texas|
|The University of Texas M. D. Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Jeffrey Weinberg, MD 713-792-2400 firstname.lastname@example.org|
|Principal Investigator:||Jeffrey Weinberg, MD||MD Anderson Cancer Center, Houston, TX|