相关临床试验
74
27 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
2014
进行中（未招募）
25
33.8%
已完成
14
18.9%
尚未招募
2
2.7%
招募中
26
35.1%
暂停
1
1.4%
终止
5
6.8%
撤回
1
1.4%
暂无批准数据
- Medicare's MolDX program, administered by Palmetto GBA, has proposed ending coverage for DCIS biomarker tests including DCISionRT, citing insufficient evidence versus existing clinicopathologic tools. - A 2024 study of 2,007 women across 63 sites found physician radiation recommendations changed in 38% of cases after DCISionRT results, moving decisions in both directions. - A head-to-head analysis of 926 patients found women reclassified as high-risk by the test had a 10-year recurrence rate of 21.4% without radiation versus 6.4% with it. - The dispute could shape future Medicare coverage of precision-medicine diagnostics, with concerns raised about a potential two-tier system for older versus commercially insured patients.
- The NRG-BN001 Phase II trial demonstrated that proton therapy at 75 Gy improved overall survival in newly diagnosed glioblastoma patients compared to standard photon therapy. - Proton therapy showed a hazard ratio for death of 0.81 with absolute survival benefits of 6.8% at two years and 4.6% at three years. - The treatment reduced severe lymphopenia rates to 17.1% versus 23.4% with photon therapy, potentially preserving immune function critical for anti-tumor response. - These promising results have met the predefined threshold for advancement to a definitive Phase III randomized trial to confirm the therapeutic advantage.
- The phase II BALANCE trial validated PAM50 as the first predictive biomarker for hormone therapy response in recurrent prostate cancer, identifying patients with luminal B tumors who benefit significantly from apalutamide treatment. - Patients with luminal B tumors showed 72.4% five-year biochemical progression-free survival with apalutamide versus 53.9% with placebo, while non-luminal B patients saw no benefit from hormone therapy. - The genomic test could revolutionize treatment personalization by recommending hormone therapy only for responsive patients while sparing others from unnecessary side effects. - Results were so definitive that researchers believe a phase III confirmatory trial would be unethical, suggesting rapid clinical implementation of PAM50 testing in recurrent prostate cancer management.
- The phase 3 PREDICT-RT trial has successfully enrolled 2,478 patients across US and Canada to test individualized treatment approaches for high-risk prostate cancer using Decipher genomic testing. - Patients with low Decipher scores will receive de-intensified treatment comparing 12 months versus 24 months of androgen deprivation therapy with radiation. - High-risk patients with elevated Decipher scores will test whether adding apalutamide to standard radiation and hormone therapy improves metastasis-free survival. - The study represents a major advancement in precision oncology for prostate cancer, with results expected to guide personalized treatment decisions and improve patient quality of life.
- The phase 3 ARCHER trial (NRG-GU015) is now enrolling 486 patients to compare ultra-hypofractionated stereotactic body radiation therapy (5 treatments) versus standard hypofractionated radiotherapy (20 treatments) for muscle invasive bladder cancer. - Up to 20% of muscle invasive bladder cancer patients currently forego curative treatment due to logistical concerns related to frequent visits to specialized centers over several months. - The study aims to determine if the shortened radiation regimen can maintain bladder-intact event-free survival at 3 years while reducing patient burden and improving quality of life. - Translational research components include circulating tumor DNA analysis as a biomarker for predicting disease recurrence and guiding future personalized treatment approaches.
- The NRG-BN007 phase II trial found that combining ipilimumab and nivolumab with radiation therapy did not improve progression-free survival compared to standard temozolomide plus radiation in newly diagnosed MGMT-unmethylated glioblastoma patients. - Median progression-free survival was 7.7 months in the immunotherapy arm versus 8.5 months in the temozolomide arm, with a hazard ratio of 1.47 favoring the control group. - The trial enrolled 159 patients and was designed to detect superior efficacy, but the failure to meet the primary endpoint led to closure of accrual and cancellation of the planned phase III study. - Researchers emphasize the continued need for novel therapeutic approaches in this aggressive brain cancer, with ongoing biomarker analyses to identify potential patient subsets who might benefit from checkpoint inhibition.
- The NRG-BR003 phase 3 trial found that adding carboplatin to standard paclitaxel and doxorubicin/cyclophosphamide chemotherapy did not provide statistically significant improvements in survival outcomes for triple-negative breast cancer patients. - Among 769 patients followed for a median of 79.4 months, the carboplatin group showed a 5-year invasive disease-free survival rate of 82.9% compared to 77.8% in the control group, but this difference was not statistically significant. - The addition of carboplatin increased grade 3 or higher adverse events from 51.1% to 72.9% without meeting efficacy criteria across the entire study population. - Results suggest that carboplatin may not provide substantial clinical advantages for most TNBC patients, though planned translational research may identify specific subpopulations who could benefit.
- The NRG-NSABP B-51/RTOG 1304 trial found that regional nodal irradiation does not reduce invasive breast cancer recurrence in patients whose axillary nodes converted from positive to negative after neoadjuvant chemotherapy. - Among 1,641 patients, five-year recurrence-free rates were nearly identical between treatment groups at 91.8% without radiation and 92.7% with radiation (HR=0.88, p=0.51). - The findings suggest pathologic complete response in axillary nodes serves as a biomarker identifying patients who derive no benefit from additional regional radiation therapy. - Results challenge current treatment paradigms and support more personalized radiation strategies based on response to neoadjuvant chemotherapy rather than initial nodal status.
• Flatiron Health and NRG Oncology have partnered to implement Flatiron Clinical Pipe, an EHR-to-EDC connector technology, in a multi-center oncology trial to enhance data entry efficiency. • The technology enables rapid transfer of thousands of data points directly from electronic health records, eliminating the need for source data verification and potentially reducing administrative burden on research staff. • A correlative study will be conducted alongside the implementation to evaluate the efficiency of Flatiron Clinical Pipe compared to traditional data entry methods in clinical trials.
- Cortechs.ai and EDAP TMS SA achieved a milestone with the first-ever OnQ Prostate-assisted Focal One Robotic HIFU procedure performed at UCSF Prostate Center. - UCLA researchers found that early radiation therapy side effects in prostate cancer patients may indicate higher risks of serious long-term urinary and bowel complications. - Vanderbilt researchers discovered that the inherited mutated WNT9B gene, crucial in embryonic prostate development, increases adult prostate cancer risk.
