Laser treatment for recurrent high-grade glioma

Randomized Clinical Trial of Efficiency and Safety of Recurrent High Grade Glioma Treated by Laser Interstitial Thermal Therapy

This study tests if a new laser treatment can help people with recurrent high-grade glioma live longer without their cancer getting worse compared to standard treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 135 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Tiantan Hospital (Academic / other)
• Locations: 9 sites (Beijing, Beijing Municipality and 8 other locations)
• Trial ID: NCT06161610 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and effectiveness of laser interstitial thermal therapy (LITT) for patients with recurrent high-grade glioma (rHGG). Participants will be randomly assigned to receive either LITT or standard treatment, with the primary goal of assessing progression-free survival. The study aims to enroll 135 patients, with 90 receiving LITT and 45 in the control group. The trial will evaluate whether LITT can improve survival outcomes compared to existing therapies.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of grade 3 or 4 glioma who have experienced disease progression after standard treatment.

Not a fit: Patients with gliomas that do not meet the specified criteria or those who are not suitable for the intervention may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates for patients with recurrent high-grade glioma.

How similar studies have performed: Other studies have shown promising results with laser therapies for brain tumors, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Aged 18 years old or above;
2. Patients with previous pathological diagnosis of 2021 World Health Organization Classification of Central Nervous System Tumors (WHO CNS5) grade 3 or 4 glioma and received standard treatment;
3. Meet any of the following:

   1. Meets the disease progression criteria in the Response Evaluation of Neuro-Oncology (RANO 2.0) criteria;
   2. At least one image other than T1 contrast indicates progression;
   3. Pathology shows progression or recurrence;
   4. Other progress determined by the Clinical Events Committee (CEC);
4. All tumor lesions are located supratentorial and the maximum cross-sectional short-axis length in the T1 contrast is ≤30 mm;
5. Karnofsky score (KPS) ≥ 60 and the patient can tolerate the intervention;
6. The subjects or their agent can understand the purpose of the trial, show sufficient compliance with the trial protocol, and sign the informed consent form.

Exclusion Criteria:

1. Patients may benefit from other treatments or may not benefit from this trial;
2. No more than three months since the patient underwent craniotomy;
3. MRI contrast cannot be performed;
4. Severe coagulation disorder;
5. Women who are pregnant, lactating, or planning to become pregnant within 6 months;
6. Participated in any other clinical trials of drugs or medical devices within 3 months;
7. Combined diseases that may interfere with treatment or prognosis assessment;
8. Refuse or unlikely to complete follow-up assessment;
9. Other circumstances in which the researcher deems it inappropriate to participate in this clinical trial.

Where this trial is running

Beijing, Beijing Municipality and 8 other locations

• Beijing Tiantan Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Beijing Tsinghua Changgung Hospital — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• The First Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)
• Tongji Hospital — Wuhan, Hubei, China (Recruiting)
• The First Hospital of Jilin University — Changchun, Jilin, China (Recruiting)
• The Peoples Hospital of Liaoning — Shenyang, Liaoning, China (Recruiting)
• Qilu Hospital — Jinan, Shandong, China (Recruiting)
• Huashan Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Tao Jiang, MD — Beijing Tiantan Hospital
• Study coordinator: Yunke Li, MD

Conditions Recurrent High Grade Glioma; laser interstitial thermal therapy