Recurrent High Grade Glioma Treated by LITT
ConditionRecurrent High Grade Glioma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Tiantan Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
LITT
DeviceThe 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 interventionThe patients in the control group will receive the best medical management under guidelines except LITT before tumor progression. Craniotomy will not be restricted,
Treatment groups
135 Participants
are divided into 2 treatment groupsGroup A: LITTExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention
Trial outcomes
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.
Time frame
estimate 6 monthsSecondary outcomes
1
Lesion ablation rate
LITT group only, measured on enhanced MRI within 2 days post LITT
Time frame
within 2 days Post LITT2
Lesion remaining volume
LITT group only, measured on enhanced MRI within 2 days post LITT
Time frame
within 2 days Post LITT3
Overall survival
Time frame
up to 2 years4
Karnofsky Performance Status (KPS) shift
The difference between baseline KPS and follow-up KPS
Time frame
Day 30,Day 90, Day 180Other outcomes
1
specific AE rate
Specific AE and complication including intracerebral hemorrhage, severe edema, newly seizure, local incision wound and all SAEs
Time frame
through study completion, an average of 6 month2
bleeding volume
LITT group only during surgery
Time frame
post LITT immmediatlySponsors and contacts
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Source ClinicalTrials.gov