Recurrent High Grade Glioma Treated by LITT (REGALITT)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Recurrent High Grade Glioma
• Intervention / Treatment: Device: LITT; Other: Control

• Study Type: Interventional
• Enrollment (Estimated): 135
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yunke Li, MD; Phone Number: 0086-010-67088936; Email: liyunke@sinovationmed.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Not yet recruiting
      • Beijing Tsinghua Changgung Hospital
      • Contact: Yi Guo, MD
    • Beijing, Beijing, China
      • Recruiting
      • Beijing Tiantan Hospital
      • Contact: Diabiao Zhou, MD; Phone Number: +86 (010)-59975692; Email: dabiaozhou@163.com
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • The First Affiliated Hospital of Sun Yat-Sen University
      • Contact: Nu Zhang, MD
  • Henan
    • Zhengzhou, Henan, China
      • Recruiting
      • The first affiliated hospital of Zhengzhou university
      • Contact: Dongming Yan, MD
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • Tongji Hospital
      • Contact: Kai Shu, MD
  • Jilin
    • Changchun, Jilin, China
      • Recruiting
      • The First Hospital of Jilin University
      • Contact: Yunqian Li, MD
  • Liaoning
    • Shenyang, Liaoning, China
      • Recruiting
      • The Peoples Hospital of Liaoning
      • Contact: Peizhuo Zang, MD
  • Shandong
    • Jinan, Shandong, China
      • Recruiting
      • Qilu hospital
      • Contact: Shilei Ni, MD
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Huashan Hospital
      • Contact: Jinsong Wu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LITT; LITT+potential other treatment	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.
Active Comparator: Control; Best medical management under guidelines	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,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival	The progression was defined by RANO 2.0 criteria and assessed by the third-party clinical events committees which are blinded to the allocation.	estimate 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival		up to 2 years
Lesion ablation rate	LITT group only, measured on enhanced MRI within 2 days post LITT	within 2 days Post LITT
Lesion remaining volume	LITT group only, measured on enhanced MRI within 2 days post LITT	within 2 days Post LITT
Karnofsky Performance Status (KPS) shift	The difference between baseline KPS and follow-up KPS	Day 30,Day 90, Day 180

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
bleeding volume	LITT group only during surgery	post LITT immmediatly

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Investigators: Principal Investigator: Tao Jiang, MD, Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2023
• Primary Completion (Estimated): March 19, 2026
• Study Completion (Estimated): September 19, 2027

Study Registration Dates

• First Submitted: November 21, 2023
• First Submitted That Met QC Criteria: November 29, 2023
• First Posted (Actual): December 8, 2023

Study Record Updates

• Last Update Posted (Actual): November 29, 2024
• Last Update Submitted That Met QC Criteria: November 26, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: laser interstitial thermal therapy; Recurrent High Grade Glioma
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Disease Attributes; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Recurrence; Glioma
• Other Study ID Numbers: REGALITT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No