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Recruiting NCT06161610

Recurrent High Grade Glioma Treated by LITT

No phase Interventional Recurrent High Grade Glioma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LITT, Control.
Who it may be relevant to
Registry conditions: Recurrent High Grade Glioma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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,

Primary outcome measures

  • Progression-free survival [Time frame: estimate 6 months]
Secondary outcome measures (4)
  • Lesion ablation rate [Time frame: within 2 days Post LITT]
  • Lesion remaining volume [Time frame: within 2 days Post LITT]
  • Overall survival [Time frame: up to 2 years]
  • Karnofsky Performance Status (KPS) shift [Time frame: Day 30,Day 90, Day 180]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 9 centers
  • Beijing Tiantan Hospital — Beijing
  • Beijing Tsinghua Changgung Hospital — Beijing
  • The First Affiliated Hospital of Sun Yat-sen University — Guangzhou
  • The First Affiliated Hospital of Zhengzhou University — Zhengzhou
  • Tongji Hospital — Wuhan
  • The First Hospital of Jilin University — Changchun
  • The Peoples Hospital of Liaoning — Shenyang
  • Qilu Hospital — Jinan
  • … and 1 more center

Identifiers

NCT: NCT06161610 · REGALITT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗