Clinical trial · Interventional
Sub-lobectomy for IDH Wild-type and TERT Promoter Mutant Glioblastoma
Sub-lobectomy for IDH Wild-type and TERT Promoter Mutant Glioblastoma: A Prospective, Interventional, Multicenter, Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| imaging total resection | Procedure | — | UNRESOLVED |
| sub-lobectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- The intervention group
- description
- The intervention group was to receive frontal, temporal, parietal, and occipital sub-lobotomies that met anatomical criteria.
- interventionNames
- Procedure: sub-lobectomy
- type
- OTHER
- label
- The control group
- description
- The control group was to receive imaging total resection (T1-enhanced borders) that met RANO criteria.
- interventionNames
- Procedure: imaging total resection
Primary outcomes (1)
- measure
- Progression-free Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUND[1]. Weller M, Wick W, Aldape K, et al. Glioma. Nature Reviews Disease Primers 2015;1:15017. [2]. Schaff Lauren R,Mellinghoff Ingo K,Glioblastoma and Other Primary Brain Malignancies in Adults: A Review.[J] .JAMA, 2023, 329: 574-587. [3]. Xiong Z, Luo C, Wang P, Hameed NUF, Song S, Zhang X, Wu S, Wu J, Mao Y. The Intraoperative Utilization of Multimodalities Could Improve the Prognosis of Adult Glioblastoma: A Single-Center Observational Study. World Neurosurg. 2022 Sep;165:e532-e545. [4]. 罗宸, 吴帅, 吴劲松. 分子病理指导下的脑胶质瘤手术的研究进展.中华神经外科杂志, 2021, 37(9). 952-956. [5]. Halsted WS: I. The results of operations for the cure of cancer of the breast performed at the Johns Hopkins Hospital from June, 1889, to January, 1894. Ann Surg 20:497-555,1894. [6]. Dandy WE: Removal of right cerebral hemisphere for certain tumors with hemiplegia. J Am Med Assoc 90:823-825, 1928. [7]. Li YM, Suki D, Hess K, Sawaya R: The influence of maximum safe resection of glioblastoma on survival in 1229 patients: Can we do better than gross-total resection? J Neurosurg 124:977-988, 2016. [8]. Molinaro Annette M,Hervey-Jumper Shawn,Morshed Ramin A et al. Association of Maximal Extent of Resection of Contrast-Enhanced and Non-Contrast-Enhanced Tumor With Survival Within Molecular Subgroups of Patients With Newly Diagnosed Glioblastoma.[J] .JAMA Oncol, 2020, 6: 495-503. [9]. Roh Tae Hoon,Kang Seok-Gu,Moon Ju Hyung et al. Survival benefit of lobectomy over gross-total resection without lobectomy in cases of glioblastoma in the noneloquent area: a retrospective study.[J] .J Neurosurg, 2019, 132: 895-901. [10]de Leeuw CN, Vogelbaum MA. Supratotal resection in glioma: a systematic review. Neuro-Oncol. 2019;21(2):179-188. [11] Pessina F, Navarria P, Cozzi L, Ascolese AM, Simonelli M, Santoro A, Clerici E, Rossi M, Scorsetti M, Bello L. Maximize surgical resection beyond contrast-enhancing boundaries in newly diagnosed glioblastoma multiforme: is it useful and safe? A single institution retrospective experience. J Neurooncol. 2017 Oct;135(1):129-139. [12] Glenn CA, Baker CM, Conner AK, Burks JD, Bonney PA, Briggs RG, Smitherman AD, Battiste JD, Sughrue ME. An Examination of the Role of Supramaximal Resection of Temporal Lobe Glioblastoma Multiforme. World Neurosurg. 2018 Jun;114:e747-e755. [13] Salah M. Hamada, Ahmed H. Abou-Zeid. Anatomical resection in glioblastoma: extent of resection and its impact on duration of survival. 2016 The Egyptian Journal of Neurology, Psychiatry and Neurosurgery 1110-1083. [14] Di L, Shah AH, Mahavadi A, Eichberg DG, Reddy R, Sanjurjo AD, Morell AA, Lu VM, Ampie L, Luther EM, Komotar RJ, Ivan ME. Radical supramaximal resection for newly diagnosed left-sided eloquent glioblastoma: safety and improved survival over gross-total resection. J Neurosurg. 2022 May 27;138(1):62-69. [15] Schneider M, Potthoff AL, Keil VC, Güresir Á, Weller J, Borger V, Hamed M, Waha A, Vatter H, Güresir E, Herrlinger U, Schuss P. Surgery for temporal glioblastoma: lobectomy outranks oncosurgical-based gross-total resection. J Neurooncol. 2019 Oct;145(1):143-150. [16] Shah AH, Mahavadi A, Di L, Sanjurjo A, Eichberg DG, Borowy V, Figueroa J, Luther E, de la Fuente MI, Semonche A, Ivan ME, Komotar RJ. Survival benefit of lobectomy for glioblastoma: moving towards radical supramaximal resection. J Neurooncol. 2020 Jul;148(3):501-508. [17]. Louis DN, Perry A, Wesseling P, et al. The 2021 WHO Classification of Tumors of the Central Nervous System: a summary. Neuro-Oncology 2021;23:1231-51. [18]. Killela PJ, Reitman ZJ, Jiao Y, et al. TERT promoter mutations occur frequently in gliomas and a subset of tumors derived from cells with low rates of self-renewal. Proc Natl Acad Sci U S A 2013;110:6021-6. [19]. Ellingson BM, Wen PY, Cloughesy TF. Modified Criteria for Radiographic Response Assessment in Glioblastoma Clinical Trials. Neurotherapeutics. 2017 Apr;14(2):307-320.