Recurrent High Grade GliomaREGALITTNCT06161610
Recurrent High Grade Glioma Treated by LITT
A study testing LITT in people with Recurrent High Grade Glioma, run by Beijing Tiantan Hospital at 9 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent High Grade Glioma
- What is being tested?
- LITT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 9 sitesChina
- Study dates
- 19 Sep 2023to 19 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality
Diabiao Zhou, MD, +86 (010)-59975692, dabiaozhou@163.com
- Not yet recruiting
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality
Yi Guo, MD
- Recruiting
The First Hospital of Jilin University
Changchun, Jilin
Yunqian Li, MD
- Recruiting
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
Nu Zhang, MD
- Recruiting
Qilu Hospital
Jinan, Shandong
Shilei Ni, MD
- Recruiting
Huashan Hospital
Shanghai, Shanghai Municipality
Jinsong Wu, MD
- Recruiting
The Peoples Hospital of Liaoning
Shenyang, Liaoning
Peizhuo Zang, MD
- Recruiting
Tongji Hospital
Wuhan, Hubei
Kai Shu, MD
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Dongming Yan, MD
About this study
Official title: Randomized Clinical Trial of Efficiency and Safety of Recurrent High Grade Glioma Treated by Laser Interstitial Thermal Therapy
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:
Read more
- 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
- Being tested
- LITT, Control
- Keywords
- laser interstitial thermal therapy, Recurrent High Grade Glioma
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LITTDevice
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.
ControlOther
The patients in the control group will receive the best medical management under guidelines except LITT before tumor progression. Craniotomy will not be restricted,
| Study group | Role | What they receive |
|---|---|---|
| LITT | Experimental | LITT+potential other treatment Receives: Device: LITT |
| Control | Active comparator | Best medical management under guidelines Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: estimate 6 months
Secondary outcomes (4)
Lesion ablation rate
LITT group only, measured on enhanced MRI within 2 days post LITT
Measured: within 2 days Post LITT
Lesion remaining volume
LITT group only, measured on enhanced MRI within 2 days post LITT
Measured: within 2 days Post LITT
Overall survival
Measured: up to 2 years
Karnofsky Performance Status (KPS) shift
The difference between baseline KPS and follow-up KPS
Measured: Day 30,Day 90, Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start19 Sep 2023
- Primary completion19 Mar 2026 (estimated)
- Study completion19 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent High Grade GliomaStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dabiao Zhou, MD, Beijing Tiantan Hospital
- Investigators
- Tao Jiang, MD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06161610
- Sponsor's protocol ID
- REGALITT
- Acronym
- REGALITT
- Status last verified
- Nov 2024
- First submitted
- 21 Nov 2023
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Efficiency and Safety of Recurrent High Grade Glioma Treated by Laser Interstitial Thermal Therapy
- ClinicalTrials.gov ID
- NCT06161610
- Acronym / sponsor ID
- REGALITT / REGALITT
- Conditions
- Recurrent High Grade Glioma
- Keywords
- laser interstitial thermal therapy, Recurrent High Grade Glioma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- 19 Mar 2026 (estimated)
- Study completion
- 19 Sep 2027 (estimated)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LITT | Experimental | Device: LITTLITT+potential other treatment |
| Control | Active comparator | Other: ControlBest medical management under guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LITTThe 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. | Device | LITT |
| ControlThe patients in the control group will receive the best medical management under guidelines except LITT before tumor progression. Craniotomy will not be restricted, | Other | Control |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tao Jiang, MD principal investigator
Beijing Tiantan Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LITT in people with Recurrent High Grade Glioma, run by Beijing Tiantan Hospital at 9 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yunke Li, MD (0086-010-67088936, liyunke@sinovationmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: estimate 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.