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NCT Number: NCT06161610

Recurrent High Grade Glioma Treated by LITT

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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,

Primary outcomes

  1. Progression-free survival

    Time frame: estimate 6 months

    The progression was defined by RANO 2.0 criteria and assessed by the third-party clinical events committees which are blinded to the allocation.

Secondary outcomes

  1. Lesion ablation rate

    Time frame: within 2 days Post LITT

    LITT group only, measured on enhanced MRI within 2 days post LITT

  2. Lesion remaining volume

    Time frame: within 2 days Post LITT

    LITT group only, measured on enhanced MRI within 2 days post LITT

  3. Overall survival

    Time frame: up to 2 years

  4. Karnofsky Performance Status (KPS) shift

    Time frame: Day 30,Day 90, Day 180

    The difference between baseline KPS and follow-up KPS

Other outcomes

  1. specific AE rate

    Time frame: through study completion, an average of 6 month

    Specific AE and complication including intracerebral hemorrhage, severe edema, newly seizure, local incision wound and all SAEs

  2. bleeding volume

    Time frame: post LITT immmediatly

    LITT group only during surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Yunke Li, MD

CONTACT

[email protected]

0086-010-67088936

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

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

Acronym: REGALITT

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Dec 8, 2023
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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