Primary GlioblastomaPhase 3EMITTNCT05318612
Effectiveness of MR-guided LITT Therapy in Irresectable Glioblastoma (EMITT)
A Phase 3 study testing Laser Interstitial Thermal Therapy (LITT) and Biopsy in people with Primary Glioblastoma, run by Radboud University Medical Center at 7 sites in Netherlands.
Trial summary
The aim of this study is to investigate the (cost-)effectiveness of LITT (Laser Interstitial Thermal Therapy) in primary irresectable glioblastoma. Glioblastoma are the most common malignant brain tumors and are, due to their devastating nature and the fact that these tumors occur at a relatively young age (median 59… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Glioblastoma
- What is being tested?
- Laser Interstitial Thermal Therapy (LITT) and Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 7 sitesNetherlands
- Study dates
- 8 Apr 2022to 31 Oct 2027
- Phase
- Phase 3
- 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
- Informed consent, age >18 years
- Suspected glioblastoma
- Supratentorial localization
- Patient is not amendable for surgical resection as decided by the tumor board
- Safe trajectory/trajectories possible for ablation of at least 70% of the tumor, avoiding eloquent structures
- Karnofsky Performance Status (KPS) >=70
Who cannot join
- Contra-indication for general anesthesia or MRI
- Non-glioblastoma diagnosis on pathology analysis
- No final pathology available
- Pregnancy
- Insufficient command of the Dutch language by the patient or a family member, making it impossible to fill in the questionnaires
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Netherlands7 sites
Amsterdam Medical Center
Amsterdam
University Medical Center Groningen
Groningen
Maastricht University Medical Center
Maastricht
Radboud University Medical Center
Nijmegen
Erasmus Medical Center
Rotterdam
Elisabeth Tweesteden Ziekenhuis
Tilburg
University Medical Center Utrecht
Utrecht
About this study
Official title: (Cost)Effectiveness of MR-guided LITT Therapy in Patients With Primary Irresectable Glioblastoma: a Prospective Multicenter Randomized Controlled Trial (EMITT)
The aim of this study is to investigate the (cost-)effectiveness of LITT (Laser Interstitial Thermal Therapy) in primary irresectable glioblastoma. Glioblastoma are the most common malignant brain tumors and are, due to their devastating nature and the fact that these tumors occur at a relatively young age (median 59 years), responsible for up to 7% of total life years lost from cancer before the age of 70.
The current treatment of glioblastoma consists of maximal safe surgery combined with adjuvant chemoradiation therapy (CRT). However, despite this aggressive treatment, these patients still face a poor prognosis (median overall survival 14.5 - 18.5 months). In addition to that, around 30% of the patients diagnosed with a glioblastoma are not suitable for surgery. These patients miss the benefit of a resection and face an even worse prognosis (median overall survival 5.1 months).
The primary aim of this project is to investigate whether laser therapy combined with CRT improves overall survival, without compromising quality of life, in comparison with CRT alone in patients with primary irresectable glioblastoma.
Read the detailed description
RATIONALE: Glioblastoma (GBM) is the most common primary brain tumor with about 1000 new patients facing this diagnosis each year in the Netherlands alone. It is also one of the most devastating malignancies and due to relatively young age at presentation (median 59 years), GBMs are responsible for up to 7% of total life years lost from cancer before the age of 70. Despite many efforts, patients with glioblastoma face a poor prognosis, with 2-year survival less than 20%. Current standard of care includes maximal safe surgical resection followed by adjuvant chemoradiation therapy (CRT). Subtotal and gross total resection have been associated with significantly longer survival (median OS: 14.5-18.5 months; RR: 0.71-0.84) 6,7, but in 30% of patients surgery is not feasible. These patients miss the benefit of surgical resection and with CRT alone have a profoundly worse survival (median 5.1 months). Laser interstitial thermal therapy (LITT) is recently growing as a minimally invasive alternative to treat brain tumors. Multiple studies have shown the application of LITT in newly diagnosed and recurrent glioblastoma, in radiotherapy and chemotherapy resistant metastases or in tumors in difficult accessible locations, with promising initial results. A recent systematic review of current phase I/II studies in patients with newly diagnosed irresectable glioblastoma who received LITT yields a mean survival of 10.2 months, i.e. twice as long as with CRT alone (5.1 months). However, there is currently no high-quality prospective evidence directly comparing LITT with standard of care, precluding any conclusions on (cost-)effectiveness. After conducting a pilot study at Radboud University Medical Center to locally confirm safety and feasibility of LITT in patients with irresectable glioblastoma, we propose a prospective multicenter randomized controlled study to evaluate (cost-)effectiveness of this technique.
OBJECTIVE: The primary objective is to prove an improvement in survival without substantially compromising quality-of-life (QoL) in patients with primary irresectable glioblastoma (GBM) treated with LITT plus chemoradiation therapy (CRT) vs. CRT alone.
STUDY DESIGN: Prospective multicenter randomized controlled trial. Study population: Adult (>18 years old) patients with a radiologically suspected diagnosis of primary glioblastoma not amenable for surgical resection.
INTERVENTION: Patients will be randomized to receive either (i) biopsy and LITT, followed by standard CRT or (ii) biopsy alone, followed by standard CRT.
MAIN STUDY PARAMETERS/ENDPOINTS: The primary endpoints are overall survival (OS) and quality-of-life (QoL) using QLQ-C30+BN20 questionnaire 5 months after randomization.
Secondary endpoints are disease-specific and progression-free survival (PFS), generic QoL using EQ5D-5L and QLQ-C30+BN20, complication rates, tumor volume response, effects on adjuvant treatment and costs.
NATURE AND EXTENT OF THE BURDER AND RISKS ASSOCIATED WITH PARTICIPATION, BENEFIT AND GROUP RELATEDNESS: We hypothesize that the addition of LITT provides patients with an irresectable glioblastoma a relevant survival benefit without compromising their quality of life as compared to current standard treatment. LITT has been shown to carry limited risk of post-operative complications, mostly reversible, and has been associated with fast recovery post-treatment. The main risks associated to the procedure are bleeding, brain edema, neurological deterioration, operation site infection, epilepsy. The results of our near-finished pilot study are showing that the procedure seems to be safe and feasible.
- Conditions
- Primary Glioblastoma
- Being tested
- Laser Interstitial Thermal Therapy (LITT), Biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser Interstitial Thermal Therapy (LITT)Procedure or surgery
LITT is a minimally invasive neurosurgical procedure in which a laser catheter is placed into the tumor and warms the tumor to such an extent that tumor tissue is destroyed. LITT is performed under MR-guidance.
BiopsyProcedure or surgery
A sample of tissue from the tumor is obtained to confirm the diagnosis.
| Study group | Role | What they receive |
|---|---|---|
| Control group (biopsy group) | Other | Standard of care: biopsy + adjuvant treatment Receives: Procedure: Biopsy |
| Intervention group (LITT group) | Experimental | Biopsy + LITT + adjuvant treatment Receives: Procedure: Laser Interstitial Thermal Therapy (LITT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Percentage of patients still alive for a given period of time after randomization.
Measured: Depending on which event occurs first: either when a study participant dies or at the end of the trial (61 months).
Health Related Quality of Life (HR-QoL)
QoL measured with the QLQ-C30BN20 at 5 months after randomization.
Measured: At 5 months after randomization
Secondary outcomes (10)
Costs
Use of care and health-related costs measured using costs questionnaires.
Measured: At 1, 2, 3, 4, 5, 6, 12, 18, 30, 42 and 54 months after randomization.
Ablation rate
Measuring the expected ablation rate.
Measured: Using the MRI made right after LITT procedure
Progression Free Survival (PFS)
The length of time during and after the treatment of the disease that a patient lives with the disease but it does not get worse.
Measured: During the entire study period, estimated 18 months for each patient
Disease Specific Survival (DSS)
The percentage of patients who have not died from glioblastoma.
Measured: During the entire study period, estimated 18 months for each patient
Complication rate
Registration of complications in both study groups.
Measured: During the entire study period, estimated 18 months for each patient
Overall survival since intervention
Percentage of patients still alive for a given period of time after surgery.
Measured: During the entire study period, estimated 18 months for each patient
Tumor volume response
Response of tumor tissue to LITT.
Measured: Using the MRI made right after LITT procedure
Effects of LITT on adjuvant treatment
Effects of LITT on the effect of adjuvant treatment assessed by tumor response to chemotherapy and radiotherapy on follow-up MRI.
Measured: During the entire study period, estimated 18 months for each patient
General Quality of Life
QoL measured with the QoL questionnaires.
Measured: At randomization, 72 hours after surgery, 1, 2, 3, 4, 5, 6, 12, 18, 30, 42 and 54 months after randomization.
Longitudinal effects
Changes attributable to aging during the study period. Longitudinal effects will be assessed using mixed model analysis.
Measured: During the entire study period, estimated 18 months for each patient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start8 Apr 2022
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for Primary GlioblastomaStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, multicenter, open-label randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 238 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch National Health Care Institute, ZonMw: The Netherlands Organisation for Health Research and Development, UMC Utrecht
- Responsible party
- Sponsor
- Investigators
- Mark ter Laan, MD, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05318612
- Sponsor's protocol ID
- NL79202.091.21
- Acronym
- EMITT
- Status last verified
- Sep 2023
- First submitted
- 23 Mar 2022
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared with other researchers. All data will be made findable and shared for reuse and/or verification. Restrictions on data sharing only apply to MRI images due to privacy. Metadata will be published in a data repository (Radboud Data Repository). This way the data is findable. When desired, external researchers can request our data.
Publications
Incidentie Hersentumoren. IKNL. https://www.iknl.nl/kankersoorten/hersentumoren/registratie/incidentie. Accessed October 7, 2020.
Siegel RL, Miller KD, Jemal A. Cancer statistics, 2015. CA Cancer J Clin. 2015 Jan-Feb;65(1):5-29. doi: 10.3322/caac.21254. Epub 2015 Jan 5.
PubMed 25559415Rouse C, Gittleman H, Ostrom QT, Kruchko C, Barnholtz-Sloan JS. Years of potential life lost for brain and CNS tumors relative to other cancers in adults in the United States, 2010. Neuro Oncol. 2016 Jan;18(1):70-7. doi: 10.1093/neuonc/nov249. Epub 2015 Oct 12.
PubMed 26459813Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005 Mar 10;352(10):987-96. doi: 10.1056/NEJMoa043330.
PubMed 15758009Weller M, van den Bent M, Hopkins K, Tonn JC, Stupp R, Falini A, Cohen-Jonathan-Moyal E, Frappaz D, Henriksson R, Balana C, Chinot O, Ram Z, Reifenberger G, Soffietti R, Wick W; European Association for Neuro-Oncology (EANO) Task Force on Malignant Glioma. EANO guideline for the diagnosis and treatment of anaplastic gliomas and glioblastoma. Lancet Oncol. 2014 Aug;15(9):e395-403. doi: 10.1016/S1470-2045(14)70011-7.
PubMed 25079102Brown TJ, Brennan MC, Li M, Church EW, Brandmeir NJ, Rakszawski KL, Patel AS, Rizk EB, Suki D, Sawaya R, Glantz M. Association of the Extent of Resection With Survival in Glioblastoma: A Systematic Review and Meta-analysis. JAMA Oncol. 2016 Nov 1;2(11):1460-1469. doi: 10.1001/jamaoncol.2016.1373.
PubMed 27310651De Witt Hamer PC, Ho VKY, Zwinderman AH, Ackermans L, Ardon H, Boomstra S, Bouwknegt W, van den Brink WA, Dirven CM, van der Gaag NA, van der Veer O, Idema AJS, Kloet A, Koopmans J, Ter Laan M, Verstegen MJT, Wagemakers M, Robe PAJT; Quality Registry Neuro Surgery glioblastoma working group from the Dutch Society of Neurosurgery. Between-hospital variation in mortality and survival after glioblastoma surgery in the Dutch Quality Registry for Neuro Surgery. J Neurooncol. 2019 Sep;144(2):313-323. doi: 10.1007/s11060-019-03229-5. Epub 2019 Jun 24.
PubMed 31236819Haj A, Doenitz C, Schebesch KM, Ehrensberger D, Hau P, Putnik K, Riemenschneider MJ, Wendl C, Gerken M, Pukrop T, Brawanski A, Proescholdt MA. Extent of Resection in Newly Diagnosed Glioblastoma: Impact of a Specialized Neuro-Oncology Care Center. Brain Sci. 2017 Dec 25;8(1):5. doi: 10.3390/brainsci8010005.
PubMed 29295569Ashraf O, Patel NV, Hanft S, Danish SF. Laser-Induced Thermal Therapy in Neuro-Oncology: A Review. World Neurosurg. 2018 Apr;112:166-177. doi: 10.1016/j.wneu.2018.01.123. Epub 2018 Feb 2.
PubMed 29410102Viozzi I, Guberinic A, Overduin CG, Rovers MM, Ter Laan M. Laser Interstitial Thermal Therapy in Patients with Newly Diagnosed Glioblastoma: A Systematic Review. J Clin Med. 2021 Jan 19;10(2):355. doi: 10.3390/jcm10020355.
PubMed 33477796Williams D, Loshak H. Laser Interstitial Thermal Therapy for Epilepsy and/or Brain Tumours: A Review of Clinical Effectiveness and Cost-Effectiveness [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2019 Jun 17. Available from http://www.ncbi.nlm.nih.gov/books/NBK545597/
PubMed 31449372Weller M, van den Bent M, Preusser M, Le Rhun E, Tonn JC, Minniti G, Bendszus M, Balana C, Chinot O, Dirven L, French P, Hegi ME, Jakola AS, Platten M, Roth P, Ruda R, Short S, Smits M, Taphoorn MJB, von Deimling A, Westphal M, Soffietti R, Reifenberger G, Wick W. EANO guidelines on the diagnosis and treatment of diffuse gliomas of adulthood. Nat Rev Clin Oncol. 2021 Mar;18(3):170-186. doi: 10.1038/s41571-020-00447-z. Epub 2020 Dec 8.
PubMed 33293629Maringwa J, Quinten C, King M, Ringash J, Osoba D, Coens C, Martinelli F, Reeve BB, Gotay C, Greimel E, Flechtner H, Cleeland CS, Schmucker-Von Koch J, Weis J, Van Den Bent MJ, Stupp R, Taphoorn MJ, Bottomley A; EORTC PROBE Project and Brain Cancer Group. Minimal clinically meaningful differences for the EORTC QLQ-C30 and EORTC QLQ-BN20 scales in brain cancer patients. Ann Oncol. 2011 Sep;22(9):2107-2112. doi: 10.1093/annonc/mdq726. Epub 2011 Feb 15.
PubMed 21324954Taphoorn MJ, Stupp R, Coens C, Osoba D, Kortmann R, van den Bent MJ, Mason W, Mirimanoff RO, Baumert BG, Eisenhauer E, Forsyth P, Bottomley A; European Organisation for Research and Treatment of Cancer Brain Tumour Group; EORTC Radiotherapy Group; National Cancer Institute of Canada Clinical Trials Group. Health-related quality of life in patients with glioblastoma: a randomised controlled trial. Lancet Oncol. 2005 Dec;6(12):937-44. doi: 10.1016/S1470-2045(05)70432-0.
PubMed 16321761Garside R, Pitt M, Anderson R, Rogers G, Dyer M, Mealing S, Somerville M, Price A, Stein K. The effectiveness and cost-effectiveness of carmustine implants and temozolomide for the treatment of newly diagnosed high-grade glioma: a systematic review and economic evaluation. Health Technol Assess. 2007 Nov;11(45):iii-iv, ix-221. doi: 10.3310/hta11450.
PubMed 17999840
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- (Cost)Effectiveness of MR-guided LITT Therapy in Patients With Primary Irresectable Glioblastoma: a Prospective Multicenter Randomized Controlled Trial (EMITT)
- ClinicalTrials.gov ID
- NCT05318612
- Acronym / sponsor ID
- EMITT / NL79202.091.21
- Conditions
- Primary Glioblastoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 238 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Dutch National Health Care Institute, ZonMw: The Netherlands Organisation for Health Research and Development, UMC Utrecht
- Study start
- 8 Apr 2022 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 8 Apr 2022 (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.
The aim of this study is to investigate the (cost-)effectiveness of LITT (Laser Interstitial Thermal Therapy) in primary irresectable glioblastoma. Glioblastoma are the most common malignant brain tumors and are, due to their devastating nature and the fact that these tumors occur at a relatively young age (median 59 years), responsible for up to 7% of total life years lost from cancer before the age of 70.
The current treatment of glioblastoma consists of maximal safe surgery combined with adjuvant chemoradiation therapy (CRT). However, despite this aggressive treatment, these patients still face a poor prognosis (median overall survival 14.5 - 18.5 months). In addition to that, around 30% of the patients diagnosed with a glioblastoma are not suitable for surgery. These patients miss the benefit of a resection and face an even worse prognosis (median overall survival 5.1 months).
The primary aim of this project is to investigate whether laser therapy combined with CRT improves overall survival, without compromising quality of life, in comparison with CRT alone in patients with primary irresectable glioblastoma.
Detailed description
RATIONALE: Glioblastoma (GBM) is the most common primary brain tumor with about 1000 new patients facing this diagnosis each year in the Netherlands alone. It is also one of the most devastating malignancies and due to relatively young age at presentation (median 59 years), GBMs are responsible for up to 7% of total life years lost from cancer before the age of 70. Despite many efforts, patients with glioblastoma face a poor prognosis, with 2-year survival less than 20%. Current standard of care includes maximal safe surgical resection followed by adjuvant chemoradiation therapy (CRT). Subtotal and gross total resection have been associated with significantly longer survival (median OS: 14.5-18.5 months; RR: 0.71-0.84) 6,7, but in 30% of patients surgery is not feasible. These patients miss the benefit of surgical resection and with CRT alone have a profoundly worse survival (median 5.1 months). Laser interstitial thermal therapy (LITT) is recently growing as a minimally invasive alternative to treat brain tumors. Multiple studies have shown the application of LITT in newly diagnosed and recurrent glioblastoma, in radiotherapy and chemotherapy resistant metastases or in tumors in difficult accessible locations, with promising initial results. A recent systematic review of current phase I/II studies in patients with newly diagnosed irresectable glioblastoma who received LITT yields a mean survival of 10.2 months, i.e. twice as long as with CRT alone (5.1 months). However, there is currently no high-quality prospective evidence directly comparing LITT with standard of care, precluding any conclusions on (cost-)effectiveness. After conducting a pilot study at Radboud University Medical Center to locally confirm safety and feasibility of LITT in patients with irresectable glioblastoma, we propose a prospective multicenter randomized controlled study to evaluate (cost-)effectiveness of this technique.
OBJECTIVE: The primary objective is to prove an improvement in survival without substantially compromising quality-of-life (QoL) in patients with primary irresectable glioblastoma (GBM) treated with LITT plus chemoradiation therapy (CRT) vs. CRT alone.
STUDY DESIGN: Prospective multicenter randomized controlled trial. Study population: Adult (>18 years old) patients with a radiologically suspected diagnosis of primary glioblastoma not amenable for surgical resection.
INTERVENTION: Patients will be randomized to receive either (i) biopsy and LITT, followed by standard CRT or (ii) biopsy alone, followed by standard CRT.
MAIN STUDY PARAMETERS/ENDPOINTS: The primary endpoints are overall survival (OS) and quality-of-life (QoL) using QLQ-C30+BN20 questionnaire 5 months after randomization.
Secondary endpoints are disease-specific and progression-free survival (PFS), generic QoL using EQ5D-5L and QLQ-C30+BN20, complication rates, tumor volume response, effects on adjuvant treatment and costs.
NATURE AND EXTENT OF THE BURDER AND RISKS ASSOCIATED WITH PARTICIPATION, BENEFIT AND GROUP RELATEDNESS: We hypothesize that the addition of LITT provides patients with an irresectable glioblastoma a relevant survival benefit without compromising their quality of life as compared to current standard treatment. LITT has been shown to carry limited risk of post-operative complications, mostly reversible, and has been associated with fast recovery post-treatment. The main risks associated to the procedure are bleeding, brain edema, neurological deterioration, operation site infection, epilepsy. The results of our near-finished pilot study are showing that the procedure seems to be safe and feasible.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, multicenter, open-label randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control group (biopsy group) | Other | Procedure: BiopsyStandard of care: biopsy + adjuvant treatment |
| Intervention group (LITT group) | Experimental | Procedure: Laser Interstitial Thermal Therapy (LITT)Biopsy + LITT + adjuvant treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Informed consent, age >18 years
- Suspected glioblastoma
- Supratentorial localization
- Patient is not amendable for surgical resection as decided by the tumor board
- Safe trajectory/trajectories possible for ablation of at least 70% of the tumor, avoiding eloquent structures
Key exclusion criteria (5 listed)
- Contra-indication for general anesthesia or MRI
- Non-glioblastoma diagnosis on pathology analysis
- No final pathology available
- Pregnancy
- Insufficient command of the Dutch language by the patient or a family member, making it impossible to fill in the questionnaires
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 |
|---|---|---|
| Laser Interstitial Thermal Therapy (LITT)LITT is a minimally invasive neurosurgical procedure in which a laser catheter is placed into the tumor and warms the tumor to such an extent that tumor tissue is destroyed. LITT is performed under MR-guidance. | Procedure or surgery | Intervention group (LITT group) |
| BiopsyA sample of tissue from the tumor is obtained to confirm the diagnosis. | Procedure or surgery | Control group (biopsy group) |
Primary outcome
Overall survival
Time frame: Depending on which event occurs first: either when a study participant dies or at the end of the trial (61 months).
Percentage of patients still alive for a given period of time after randomization.
Health Related Quality of Life (HR-QoL)
Time frame: At 5 months after randomization
QoL measured with the QLQ-C30BN20 at 5 months after randomization.
10 secondary outcomes
Costs
Time frame: At 1, 2, 3, 4, 5, 6, 12, 18, 30, 42 and 54 months after randomization.
Ablation rate
Time frame: Using the MRI made right after LITT procedure
Progression Free Survival (PFS)
Time frame: During the entire study period, estimated 18 months for each patient
Disease Specific Survival (DSS)
Time frame: During the entire study period, estimated 18 months for each patient
Complication rate
Time frame: During the entire study period, estimated 18 months for each patient
Overall survival since intervention
Time frame: During the entire study period, estimated 18 months for each patient
Tumor volume response
Time frame: Using the MRI made right after LITT procedure
Effects of LITT on adjuvant treatment
Time frame: During the entire study period, estimated 18 months for each patient
General Quality of Life
Time frame: At randomization, 72 hours after surgery, 1, 2, 3, 4, 5, 6, 12, 18, 30, 42 and 54 months after randomization.
Longitudinal effects
Time frame: During the entire study period, estimated 18 months for each patient.
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 10 Apr 2024.
- BackgroundIncidentie Hersentumoren. IKNL. https://www.iknl.nl/kankersoorten/hersentumoren/registratie/incidentie. Accessed October 7, 2020.
- Background: PubMed 25559415Siegel RL, Miller KD, Jemal A. Cancer statistics, 2015. CA Cancer J Clin. 2015 Jan-Feb;65(1):5-29. doi: 10.3322/caac.21254. Epub 2015 Jan 5.
- Background: PubMed 26459813Rouse C, Gittleman H, Ostrom QT, Kruchko C, Barnholtz-Sloan JS. Years of potential life lost for brain and CNS tumors relative to other cancers in adults in the United States, 2010. Neuro Oncol. 2016 Jan;18(1):70-7. doi: 10.1093/neuonc/nov249. Epub 2015 Oct 12.
- Background: PubMed 15758009Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005 Mar 10;352(10):987-96. doi: 10.1056/NEJMoa043330.
- Background: PubMed 25079102Weller M, van den Bent M, Hopkins K, Tonn JC, Stupp R, Falini A, Cohen-Jonathan-Moyal E, Frappaz D, Henriksson R, Balana C, Chinot O, Ram Z, Reifenberger G, Soffietti R, Wick W; European Association for Neuro-Oncology (EANO) Task Force on Malignant Glioma. EANO guideline for the diagnosis and treatment of anaplastic gliomas and glioblastoma. Lancet Oncol. 2014 Aug;15(9):e395-403. doi: 10.1016/S1470-2045(14)70011-7.
- Background: PubMed 27310651Brown TJ, Brennan MC, Li M, Church EW, Brandmeir NJ, Rakszawski KL, Patel AS, Rizk EB, Suki D, Sawaya R, Glantz M. Association of the Extent of Resection With Survival in Glioblastoma: A Systematic Review and Meta-analysis. JAMA Oncol. 2016 Nov 1;2(11):1460-1469. doi: 10.1001/jamaoncol.2016.1373.
- Background: PubMed 31236819De Witt Hamer PC, Ho VKY, Zwinderman AH, Ackermans L, Ardon H, Boomstra S, Bouwknegt W, van den Brink WA, Dirven CM, van der Gaag NA, van der Veer O, Idema AJS, Kloet A, Koopmans J, Ter Laan M, Verstegen MJT, Wagemakers M, Robe PAJT; Quality Registry Neuro Surgery glioblastoma working group from the Dutch Society of Neurosurgery. Between-hospital variation in mortality and survival after glioblastoma surgery in the Dutch Quality Registry for Neuro Surgery. J Neurooncol. 2019 Sep;144(2):313-323. doi: 10.1007/s11060-019-03229-5. Epub 2019 Jun 24.
- Background: PubMed 29295569Haj A, Doenitz C, Schebesch KM, Ehrensberger D, Hau P, Putnik K, Riemenschneider MJ, Wendl C, Gerken M, Pukrop T, Brawanski A, Proescholdt MA. Extent of Resection in Newly Diagnosed Glioblastoma: Impact of a Specialized Neuro-Oncology Care Center. Brain Sci. 2017 Dec 25;8(1):5. doi: 10.3390/brainsci8010005.
- Background: PubMed 29410102Ashraf O, Patel NV, Hanft S, Danish SF. Laser-Induced Thermal Therapy in Neuro-Oncology: A Review. World Neurosurg. 2018 Apr;112:166-177. doi: 10.1016/j.wneu.2018.01.123. Epub 2018 Feb 2.
- Background: PubMed 33477796Viozzi I, Guberinic A, Overduin CG, Rovers MM, Ter Laan M. Laser Interstitial Thermal Therapy in Patients with Newly Diagnosed Glioblastoma: A Systematic Review. J Clin Med. 2021 Jan 19;10(2):355. doi: 10.3390/jcm10020355.
- Background: PubMed 31449372Williams D, Loshak H. Laser Interstitial Thermal Therapy for Epilepsy and/or Brain Tumours: A Review of Clinical Effectiveness and Cost-Effectiveness [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2019 Jun 17. Available from http://www.ncbi.nlm.nih.gov/books/NBK545597/
- Background: PubMed 33293629Weller M, van den Bent M, Preusser M, Le Rhun E, Tonn JC, Minniti G, Bendszus M, Balana C, Chinot O, Dirven L, French P, Hegi ME, Jakola AS, Platten M, Roth P, Ruda R, Short S, Smits M, Taphoorn MJB, von Deimling A, Westphal M, Soffietti R, Reifenberger G, Wick W. EANO guidelines on the diagnosis and treatment of diffuse gliomas of adulthood. Nat Rev Clin Oncol. 2021 Mar;18(3):170-186. doi: 10.1038/s41571-020-00447-z. Epub 2020 Dec 8.
- Individual participant dataSharing planned: Yes. Data will be shared with other researchers. All data will be made findable and shared for reuse and/or verification. Restrictions on data sharing only apply to MRI images due to privacy. Metadata will be published in a data repository (Radboud Data Repository). This way the data is findable. When desired, external researchers can request our data.
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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. This study is not recruiting at the moment.
Mark ter Laan, MD, PhD principal investigator
Radboud University Medical Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Laser Interstitial Thermal Therapy (LITT) and Biopsy in people with Primary Glioblastoma, run by Radboud University Medical Center at 7 sites in Netherlands.
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 6 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Netherlands. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: Depending on which event occurs first: either when a study participant dies or at the end of the trial (61 months).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05318612, which also lists 37 linked publications.
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 10 Apr 2024.