Recurrent High Grade Glioma Treated by LITT (REGALITT)

Capital Medical University

Status: Enrolling

Conditions: Recurrent High Grade Glioma

Treatments: Other: Control; Device: LITT

Study type: Interventional

Funder types: Other

Identifiers

NCT06161610

REGALITT

Details and patient eligibility

About

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.

Enrollment: 135 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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135 participants in 2 patient groups

LITT

Experimental group

Description:

LITT+potential other treatment

Treatment:

Device: LITT

Control

Active Comparator group

Description:

Best medical management under guidelines

Treatment:

Other: Control