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Tests a wider brain surgery for a type of glioblastoma brain tumor

Compares removing a larger brain area around glioblastoma with standard imaging-guided tumor removal.

Plain-language title generated from the registry record
Registry title: Sub-lobectomy for IDH Wild-type and TERT Promoter Mutant Glioblastoma

Key facts

Where
Shanghai, ChinaSee the site

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a newly diagnosed high-grade brain tumor (glioblastoma, IDH wild-type with a TERT promoter mutation) in one lobe of the brain, who can have the whole tumor removed on imaging.

Age
18 to 80 years
Sex
All sexes
Disease stage
Newly diagnosed high-grade diffuse adult-type glioma above the tentorium, only in one frontal, temporal, parietal or occipital lobe on one side. Imaging must show that the whole tumor can be removed.
Earlier treatment
No treatment before, except a needle biopsy. Must receive the Stupp protocol after surgery.
Biomarker or test result
During surgery, the tumor must be IDH wild-type with a TERT promoter mutation.

Main reasons for not taking part

  • Tumor involves the central gyri, limbic lobe, corpus callosum, basal ganglia or lateral ventricles
  • Tumor involves 2 or more lobes
  • Severe kidney, liver or heart disease
  • Another malignant tumor before, or another brain disease such as Parkinson's or Alzheimer's
  • Expected survival less than 3 months

Read by machine on 9 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 80 years old?

Source: NCT06368934, who can take part

Where in China

  • Hushan Hospital, Fudan UniversityShanghai, ChinaNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Huashan Hospital
Trial code
NCT06368934
Record updated
16 April 2024
Original description
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.Read full original descriptionShow less

Sub-lobectomy for IDH Wild-type and TERT Promoter Mutant Glioblastoma: A Prospective, Interventional, Multicenter, Randomized Controlled Trial

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.

Inclusion: 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: Previously, the patient had experienced other types of malignant tumours; Not receiving Stupp protocol after surgery; Developing severe systemic diseases such as renal insufficiency, hepatic insufficiency, cardiac insufficiency, etc; Developing other brain diseases, such as Parkinson's or Alzheimer's disease; 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; Simultaneously participating in other clinical trials; Expected survival is less than 3 months.

ClinicalTrials.gov NCT06368934