Sub-lobectomy for IDH Wild-type and TERT Promoter Mutant Glioblastoma (NCT06368934) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Sub-lobectomy for IDH Wild-type and TERT Promoter Mutant Glioblastoma
China326 participantsStarted 2024-04-08
Plain-language summary
Glioblastoma is recognized as the most common and aggressive form of primary malignant brain tumor, with treatment options that are limited and prognosis that is extremely poor, showing median progression-free survival of 12 months and median overall survival of less than 18 months. Surgical resection plays a critical role in the treatment, with the extent of resection significantly impacting patient outcomes. Historical approaches to surgical resection have evolved, moving from radical strategies to more conservative ones that aim to preserve normal brain function while removing the tumor as completely as possible. Recent studies have suggested that increasing the extent of surgical resection, particularly along the T2 FLAIR border rather than the traditional T1-enhanced border, can significantly improve patient prognosis. There is, however, a lack of consensus on the optimal surgical approach, and the heterogeneity of tumors presents challenges in standardizing surgical strategies. Extended resection has been shown to prolong survival, and novel intraoperative molecular diagnostics have emerged to improve accuracy in tumor classification and prognosis. Building on these advancements, a multicenter, prospective, randomized controlled trial is proposed to evaluate the efficacy of sub-lobectomy in treating IDH wild-type/TERTp-mutant glioblastoma, aiming to improve evidence levels and establish standardized surgical practices for this devastating disease.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Eligible patients are aged between 18 and 80, have newly diagnosed high-grade diffuse adult-type gliomas, and have not received any other treatment besides puncture biopsy.
✓. Preoperative KPS score ≥70.
✓. Enhanced MRI can be tolerated.
✓. Sign the informed consent form.
✓. Patients with supratentorial gliomas and lesions confined to the unilateral frontal, temporal, parietal, and occipital lobes are included.
✓. Imaging total resection can be completed after preoperative imaging evaluation.
✓. The intraoperative integrative diagnosis was IDH wild-type high-grade glioma with TERT promoter mutation.
Exclusion criteria
✕. The tumor involves the anterior central gyrus, posterior central gyrus, nigral gyrus, limbic lobe, corpus callosum, basal ganglia, and lateral ventricles.
✕. The tumor involves 2 or more lobes of the brain;
What they're measuring
1
Progression-free Survival
Timeframe: From date of randomization until the date of first documented progression, assessed up to 36 months