相关临床试验
5
2 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
N/A
进行中（未招募）
2
40.0%
招募中
2
40.0%
撤回
1
20.0%
暂无批准数据
- The ROADS Phase 3 trial demonstrated that cesium-131 collagen tile-based radiation therapy (TBRT) dramatically reduced surgical site recurrence to 1.3% compared to 15.4% with standard stereotactic radiation therapy. - Patients receiving TBRT achieved median overall survival of 42.5 months, more than double the 17.6 months seen with standard care. - The FDA-cleared GammaTile treatment allows patients to complete cranial radiation in one day versus 32 days for conventional therapy, enabling faster return to systemic cancer treatments. - Superior efficacy was achieved without increased side effects, with radiation necrosis rates nearly identical between treatment groups.
- GammaTile, a bioabsorbable collagen implant with embedded radiation seeds, demonstrated superior tumor control compared to standard of care in the phase 3 ROADS trial, reducing the risk of tumor recurrence or death by more than 50% (hazard ratio 0.42, p=0.0024). - The interim analysis of 168 patients with newly diagnosed operable brain metastases showed that GammaTile provides immediate radiation therapy at the time of surgery, eliminating treatment delays that can allow microscopic cancer cells to regrow. - More than half of GammaTile patients remained free from both tumor regrowth and radiation-related tissue damage, while more than half of standard care patients experienced these events by 16-18 months (hazard ratio 0.32, p=0.018). - The treatment demonstrated significant efficacy gains without increased safety concerns, with comparable rates of treatment-related adverse effects between both groups.
