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RECRUITING
NCT06161610
NA

Recurrent High Grade Glioma Treated by LITT

Sponsor: Beijing Tiantan Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

135

Start Date

2023-09-19

Completion Date

2027-09-19

Last Updated

2024-11-29

Healthy Volunteers

No

Interventions

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 (9)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Tongji Hospital

Wuhan, Hubei, China

The First Hospital of Jilin University

Changchun, Jilin, China

The Peoples Hospital of Liaoning

Shenyang, Liaoning, China

Qilu Hospital

Jinan, Shandong, China

Huashan Hospital

Shanghai, Shanghai Municipality, China