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Clinical Trials in China / NCT06368934
Starting soon Not applicable

Sub-lobectomy for IDH Wild-type and TERT Promoter Mutant Glioblastoma

NCT06368934 · tracked via the Priya Life Science China tracker
Sponsor
Huashan Hospital
Phase
Not applicable
Started
2024-04-08
Last updated
2024-04-16

Condition(s) studied

GliomaGlioblastoma

Investigational drug(s) / intervention(s)

sub-lobectomyimaging total resection

sub-lobectomy: Combined with previous research and our team's precise neurosurgery concept, we define the surgical strategy based on lobectomy and further preserving the brain parenchyma in functional areas according to anatomical landmarks and electrophysiological boundaries as sub-lobectomy.

imaging total resection: Imaging total resection (T1-enhanced borders) will met the RANO criteria

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. 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. 2. Preoperative KPS score ≥70. 3. Enhanced MRI can be tolerated. 4. Sign the informed consent form. 5. Patients with supratentorial gliomas and lesions confined to the unilateral frontal, temporal, parietal, and occipital lobes are included. 6. Imaging total resection can be completed after preoperative imaging evaluation. 7. The intraoperative integrative diagnosis was IDH wild-type high-grade glioma with TERT promoter mutation. Exclusion Criteria: 1. The tumor involves the anterior central gyrus, posterior central gyrus, nigral gyrus, limbic lobe, corpus callosum, basal ganglia, and lateral ventricles. 2. The tumor involves 2 or more lobes of the brain; 3. Developing severe systemic diseases such as renal insufficiency, hepatic insufficiency, cardiac insufficiency, etc. 4. Previously, the patient had experienced other types of malignant tumours. 5. Developing other brain diseases, such as Parkinson's or Alzheimer's disease. 6. Simultaneously participating in other clinical trials. 7. Expected survival is less than 3 months. 8. Not receiving Stupp protocol after surgery.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hushan Hospital, Fudan University Shanghai Shanghai Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06368934 on ClinicalTrials.gov ↗ ← All trials in China