Recurrent High Grade Glioma Treated by LITT

NCT06161610 | Recruiting DMC

• 1 other identifier: REGALITT
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Recurrent High Grade Glioma

Keywords

laser interstitial thermal therapy; Recurrent High Grade Glioma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Lesion ablation rate

  within 2 days Post LITT

• Lesion remaining volume

  within 2 days Post LITT

• Overall survival

  up to 2 years

• Karnofsky Performance Status (KPS) shift

  Day 30,Day 90, Day 180

Other Outcomes (2)

• specific AE rate

  through study completion, an average of 6 month

• bleeding volume

  post LITT immmediatly

Study Arms (2)

LITT

EXPERIMENTAL

LITT+potential other treatment

Device: LITT

Control

ACTIVE COMPARATOR

Best medical management under guidelines

Other: Control

Interventions

LITT DEVICE

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.

LITT

Control OTHER

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years old or above;
• 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;
• Meet any of the following:
• Meets the disease progression criteria in the Response Evaluation of Neuro-Oncology (RANO 2.0) criteria;
• At least one image other than T1 contrast indicates progression;
• Pathology shows progression or recurrence;
• Other progress determined by the Clinical Events Committee (CEC);
• All tumor lesions are located supratentorial and the maximum cross-sectional short-axis length in the T1 contrast is ≤30 mm;
• Karnofsky score (KPS) ≥ 60 and the patient can tolerate the intervention;
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (9)

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

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Tao Jiang, MD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yunke Li, MD

CONTACT

0086-010-67088936; liyunke@sinovationmed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The progression will be assessed by third-party blinded investigators
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: December 8, 2023
• Study Start: September 19, 2023
• Primary Completion: March 19, 2026
• Study Completion (Estimated): September 19, 2027
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (9)