Recurrent High Grade Glioma Treated by LITT

Recurrent High Grade Glioma Clinical Trial

— REGALITT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06161610
• Other study ID #: REGALITT
• Status: Recruiting
• Phase: N/A
• Start date: September 19, 2023
• Est. completion date: September 19, 2027

Study information

• Verified date: February 2024
• Source: Beijing Tiantan Hospital
• Contact: Yunke Li, MD
• Phone: 0086-010-67088936
• Email: liyunke[@]sinovationmed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This clinical trial aims to investigate the efficiency and safety of laser interstitial thermal therapy (LITT) in recurrent high-grade glioma (rHGG) patients. The main questions it aims to answer are: - The LITT would increase the progression-free survival and overall survival of rHGG patients compared to other treatments. - The LITT is safe and applicable to rHGG patients Participants will be randomized to the intervention group (LITT) or control group at a ratio of 2:1. The intervention group patients will receive LITT. The control group will be treated with any other treatment. The primary outcome of this trial is progression-free survival. The estimated sample size is 135, 90 in the LITT group and 45 in the control group.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 135
• Est. completion date: September 19, 2027
• Est. primary completion date: March 19, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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) 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.

Related Conditions & MeSH terms

• Glioma
• Recurrence
• Recurrent High Grade Glioma

Intervention

Device:
• LITT
The patients in the intervention group will receive LITT, other treatments, including systematic therapy and radiology therapy, would be not restricted except the craniotomy of resection before tumor progression or emergency. The patient is supposed to receive LITT post-randomization within 7 days.

Other:
• Control
The patients in the control group will receive the best medical management under guidelines except LITT before tumor progression. Craniotomy will not be restricted,

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing	Beijing
China	Beijing Tsinghua Changgung Hospital	Beijing	Beijing
China	The First Hospital of Jilin University	Changchun	Jilin
China	The First Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong
China	Qilu Hospital	Jinan	Shandong
China	Huashan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	specific AE rate	Specific AE and complication including intracerebral hemorrhage, severe edema, newly seizure, local incision wound and all SAEs	through study completion, an average of 6 month
Other	bleeding volume	LITT group only during surgery	post LITT immmediatly
Primary	Progression-free survival	The progression was defined by RANO criteria and assessed by the third-party clinical events committees which are blinded to the allocation.	estimate 6 months
Secondary	Lesion ablation rate	LITT group only, measured on enhanced MRI within 2 days post LITT	within 2 days Post LITT
Secondary	Lesion remaining volume	LITT group only, measured on enhanced MRI within 2 days post LITT	within 2 days Post LITT
Secondary	Overall survival		up to 2 years
Secondary	Karnofsky Performance Status (KPS) shift	The difference between baseline KPS and follow-up KPS	Day 30,Day 90, Day 180