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MinorTrial status: Recruiting to Active, Not RecruitingPrimary completion date: Jul 1, 2027 to Dec 1, 2027 · Site details revised at 16 of 16 sitesv22Show 2 more changesShow less
Primary completion date: Jul 1, 2027 to Dec 1, 2027
Minor2 versionsRe-verified since Feb 13, 2024, no change to tracked fieldsv12-v13
MinorSite contacts updated at 1 of 11 sitesv11
MinorStudy sites: 10 to 11v10
MinorStudy sites: 8 to 10v9
MinorStudy sites: 7 to 8v8
MinorSite contacts updated at 3 of 7 sitesv7
MinorStudy sites: 5 to 7v6
MinorStudy sites: 4 to 5v5
MinorStudy sites: 3 to 4v4
MinorStudy sites: 1 to 3Start date changed from estimate of Sep 19, 2022 to Aug 17, 2022v3Show 1 more changeShow less
Start date changed from estimate of Sep 19, 2022 to Aug 17, 2022
NotableTrial status: Not Yet Recruiting to RecruitingStart date: May 1, 2022 to Sep 19, 2022 · Study sites: 0 to 1v2Show 2 more changesShow less
Start date: May 1, 2022 to Sep 19, 2022
Study sites: 0 to 1
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
In summary, standard of care postoperative chemoradiation for patients with newly diagnosed GBM does not routinely provide durable local control or prolonged overall survival. As discussed above it seems unlikely that patient outcomes will be significantly improved with radiation dose escalation given at the time of the EBRT boost. However, as most failures are local, improving LC could potentially improve the OS of patients. To do this, we propose a shift in the traditional radiation paradigm. This study will assess the feasibility and tolerability of adding GT radiation therapy as an upfront boost at the time of maximum safe resection, along with the backbone of the current standard of care approach, concomitant and adjuvant temozolomide +/- TTF, for patients with newly diagnosed GBM. GT, a novel brain brachytherapy device utilizing Cs-131 embedded in bioresorbable collagen tiles, offers a more sophisticated carrier and a shorter half-life radioisotope, Cs-131. Use of this device allows for radiation initiation at an earlier time point and a more rapid dose delivery and possibly more effective tumor control particularly for rapidly proliferating tumors such as GBM. Two prospective studies have demonstrated the safety and efficacy of re-irradiation with GT in patients with recurrent GBM. The overarching goal of this single-arm, open label phase 4 study is to determine the feasibility and tolerability of treating patients with GammaTile in combination with the Stupp Protocol and how to proceed with testing this treatment in a future, larger, randomized clinical study. The aims of the study are to demonstrate that the use of GammaTile at the time of surgery is well tolerated and does not delay the start of the Stupp protocol. Efficacy outcomes (e.g., LC, OS, PFS) will also be described.