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Recurrent High Grade Glioma Treated by LITT

NCT06161610 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2024-11-29

No results posted yet for this study

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

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,

Sponsors & Collaborators

  • Beijing Tiantan Hospital

    lead OTHER

Principal Investigators

  • Tao Jiang, MD · Beijing Tiantan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-19
Primary Completion
2026-03-19
Completion
2027-09-19

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06161610 on ClinicalTrials.gov