NCT06368934Not yet recruiting
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 · Last updated 16 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 326 (estimated)
- First submitted
- 27 Feb 2024
- Start date
- 8 Apr 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- Huashan Hospital
- Diseases
- Glioblastoma
- NCT number
- NCT06368934
What you commit to
- Study type: Interventional
- Planned participants: 326
- From 8 Apr 2024 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously, the patient had experienced other types of malignant tumours.
- Not receiving Stupp protocol after surgery.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hushan Hospital, Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.