High Grade GliomaEarly Phase 1NCT02970448
Expedited Laser Interstitial Thermal Therapy + Chemoradiation For Newly Diagnosed High Grade Gliomas
A Early Phase 1 study testing LITT, Radiation therapy and Temozolomide in people with High Grade Glioma, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
The investigators of this study want to see if shortening the total treatment time for brain tumors is safe.The treatment for participant's brain tumors is laser surgery (Laser Interstitial Thermal Therapy (LITT)) followed by radiation with chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Grade Glioma
- What is being tested?
- LITT, Radiation therapy and Temozolomide
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2017to 25 Oct 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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
- Subjects must have suspected high grade glioma by MRI
- Subjects must have received no prior therapies for this disease.
- Patients must be considered appropriate candidates for LITT.
- Karnofsky Performance status ≥ 60%
- Subjects must have normal organ and marrow function as defined below. Measures of function must be within 14 days prior to registration.
- Absolute neutrophil count (ANC) ≥ 1500 cells/mm3, platelets ≥ 100,000 cells/mm3, hemoglobin ≥ 10.0 g/dl. Use of transfusion or other intervention to achieve this hemoglobin level is acceptable.
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- Blood urea nitrogen ≤ 30mg/dl and creatinine ≤ 1.7 mg/dl
- Bilirubin ≤ 2.0 mg/dl, Aspartate aminotransferase/ Alanine aminotransferase (AST/ALT) ≤ 3x upper limit of normal
- Electrocardiogram without evidence of acute cardiac ischemia
- Prothrombin time/international normalized ratio (PT INR) <1.4
- Women of childbearing potential and male participants must practice adequate contraception.
- For women of childbearing age, negative pregnancy test within 14 days prior to registration
- Subjects must have the ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Participants not eligible to obtain MRI with and without contrast
- Recurrent High grade gliomas (HGG)
- Cerebral edema, grade 3 or greater prior to surgery
- Post-operative complications including significant neurological decline or hemorrhage that causes a drop in KPS to less than 60 or renders the patient not suitable for chemoradiation as determined by their treating physician
- Severe co-morbidity that would confer excess risk of surgery, radiation or chemotherapy, as determined by the treating physician.
- Any other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration of completion of protocol therapy
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- Any other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy.
- Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
- Participants receiving other investigational agents.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
About this study
Official title: Expedited Laser Interstitial Thermal Therapy and Chemoradiation for Patients With Newly Diagnosed High Grade Gliomas
The investigators of this study want to see if shortening the total treatment time for brain tumors is safe.The treatment for participant's brain tumors is laser surgery (Laser Interstitial Thermal Therapy (LITT)) followed by radiation with chemotherapy. For participants, the total time of treatment from surgery to the end of radiation and chemotherapy is about l 0 weeks long. This study asks whether it is safe to shorten the total treatment to 7 weeks.
To shorten the total treatment time, investigators want to see if it is safe to start radiation with chemotherapy within 5 days after surgery. Usually patients start their radiation with chemotherapy about 21-28 days after the surgery.
Shortening the total time of treatment may allow investigators to kill the cancer cells more effectively.
Read the detailed description
Primary Objective To determine the safety and feasibility of reducing the time interval between LITT and the start of chemoradiation to ≤ 7 days.
The primary endpoint (binary) for safety/feasibility will be defined as the occurrence of one or more of the following within each patient during a window of observation from the completion LITT to the end of radiation:
- Wound dehiscence, grade 3 {CTCAE v4.0)
- Seizures, grade 3 (CTCAE v4.0) in patients without a prior history of seizures and on adequate anti-seizure medications
- Cerebral edema, grade 4 (CTCAE v4.0)
- Failure to complete of 60 Grays (Gy) of radiation
Secondary Objective(s) To estimate the proportion of patients requiring adjustments in radiation plans post-LITT.
Secondary Endpoint: Requirement of an adjustment in the radiation plan to account for post-LITT tissue distortion.
Study design This study will be a 2-stage, single-institution safety and feasibility trial. Patients will be evaluated by a neuro-oncology team consisting of a neurosurgeon trained in LITT, radiation oncologist and medical oncologist prior to surgery. Evaluable patients will have a histologic diagnosis of high-grade glioma, complete LITT, and are candidates for standard concurrent radiation (60 Gy) and temozolomide as determined by the treating physician. Concurrent chemoradiation will begin within 7 days of the LITT procedure.
- Conditions
- High Grade Glioma
- Being tested
- LITT, Radiation therapy, Temozolomide
- Keywords
- LITT, Brain Tumor, Temozolomide
- Medical subject headings
- Glioma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LITTProcedure or surgery
Also called Laser interstitial thermal therapy
MRI-guided laser interstitial thermal therapy uses a gas cooled side-firing (directional) laser and a variety of procedure specific tools to thermally ablate target tissue in-situ.
Radiation therapyRadiation
Also called 3D-Conformal radiation therapy (RT), Intensity Modulated RT
One treatment of 2 Gy will be given daily 5 days per week for a total of 60 Gy over 6 weeks. All portals shall be treated during each treatment session. Doses are specified such that at least 95% of the planning target volume (PTV) shall receive 100% of the prescribed dose.
TemozolomideDrug
Temozolomide will be administered continuously from day 1 of radiotherapy to the last day of radiation at a daily oral dose of 75 mg/m2 for a maximum of 49 days
| Study group | Role | What they receive |
|---|---|---|
| LITT with Radiation and Temozolomide | Experimental | Laser interstitial thermal therapy (LITT) followed by Radiation therapy, three-dimensional conformal radiotherapy (3D-CRT) or intensity modulation radiation therapy (IMRT), 60 Gy/30 fractions. Radiation given with chemotherapy Temozolomide Receives: Procedure: LITT; Radiation: Radiation therapy; Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study safety as determined by the number of patients who experience pre-specified adverse events
pre-specified adverse events include: Wound dehiscence, grade 3 (CTCAE v4.0), Grade 3 Seizures (CTCAE v4.0) in patients without a prior history of seizures and on adequate anti-seizure medications, Cerebral edema, grade 4 (CTCAE v4.0), Failure to complete of 60 Gy radiation
Measured: Up to 12 weeks after LITT therapy
Secondary outcomes (1)
Number of patients with adjustments to radiation plan to account for post-LITT tissue distortion
The proportion of patients requiring a change in radiation plan after fusion of the plan with the post-operative MRI will be calculated, and a 95% confidence interval will be placed on this proportion.
Measured: Up to 12 weeks after LITT therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2016 (estimated)
- Study start24 Aug 2017
- Primary completion10 Nov 2023
- Study completion25 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Grade GliomaStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Yu, MD, PhD, Principal investigator, Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02970448
- Sponsor's protocol ID
- CASE4316
- Status last verified
- Jun 2025
- First submitted
- 18 Nov 2016
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expedited Laser Interstitial Thermal Therapy and Chemoradiation for Patients With Newly Diagnosed High Grade Gliomas
- ClinicalTrials.gov ID
- NCT02970448
- Acronym / sponsor ID
- CASE4316
- Conditions
- High Grade Glioma
- Keywords
- LITT, Brain Tumor, Temozolomide
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 24 Aug 2017 (actual)
- Primary completion
- 10 Nov 2023 (actual)
- Study completion
- 25 Oct 2024 (actual)
- First posted
- 22 Nov 2016 (estimated)
- 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 investigators of this study want to see if shortening the total treatment time for brain tumors is safe.The treatment for participant's brain tumors is laser surgery (Laser Interstitial Thermal Therapy (LITT)) followed by radiation with chemotherapy. For participants, the total time of treatment from surgery to the end of radiation and chemotherapy is about l 0 weeks long. This study asks whether it is safe to shorten the total treatment to 7 weeks.
To shorten the total treatment time, investigators want to see if it is safe to start radiation with chemotherapy within 5 days after surgery. Usually patients start their radiation with chemotherapy about 21-28 days after the surgery.
Shortening the total time of treatment may allow investigators to kill the cancer cells more effectively.
Detailed description
Primary Objective To determine the safety and feasibility of reducing the time interval between LITT and the start of chemoradiation to ≤ 7 days.
The primary endpoint (binary) for safety/feasibility will be defined as the occurrence of one or more of the following within each patient during a window of observation from the completion LITT to the end of radiation:
- Wound dehiscence, grade 3 {CTCAE v4.0)
- Seizures, grade 3 (CTCAE v4.0) in patients without a prior history of seizures and on adequate anti-seizure medications
- Cerebral edema, grade 4 (CTCAE v4.0)
- Failure to complete of 60 Grays (Gy) of radiation
Secondary Objective(s) To estimate the proportion of patients requiring adjustments in radiation plans post-LITT.
Secondary Endpoint: Requirement of an adjustment in the radiation plan to account for post-LITT tissue distortion.
Study design This study will be a 2-stage, single-institution safety and feasibility trial. Patients will be evaluated by a neuro-oncology team consisting of a neurosurgeon trained in LITT, radiation oncologist and medical oncologist prior to surgery. Evaluable patients will have a histologic diagnosis of high-grade glioma, complete LITT, and are candidates for standard concurrent radiation (60 Gy) and temozolomide as determined by the treating physician. Concurrent chemoradiation will begin within 7 days of the LITT procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LITT with Radiation and Temozolomide | Experimental | Procedure: LITT, Radiation: Radiation therapy, Drug: TemozolomideLaser interstitial thermal therapy (LITT) followed by Radiation therapy, three-dimensional conformal radiotherapy (3D-CRT) or intensity modulation radiation therapy (IMRT), 60 Gy/30 fractions. Radiation given with chemotherapy Temozolomide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects must have suspected high grade glioma by MRI
- Subjects must have received no prior therapies for this disease.
- Patients must be considered appropriate candidates for LITT.
- Karnofsky Performance status ≥ 60%
- Subjects must have normal organ and marrow function as defined below. Measures of function must be within 14 days prior to registration.
Key exclusion criteria (9 listed)
- Participants not eligible to obtain MRI with and without contrast
- Recurrent High grade gliomas (HGG)
- Cerebral edema, grade 3 or greater prior to surgery
- Post-operative complications including significant neurological decline or hemorrhage that causes a drop in KPS to less than 60 or renders the patient not suitable for chemoradiation as determined by their treating physician
- Severe co-morbidity that would confer excess risk of surgery, radiation or chemotherapy, as determined by the treating physician.
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 |
|---|---|---|
| LITTAlso: Laser interstitial thermal therapyMRI-guided laser interstitial thermal therapy uses a gas cooled side-firing (directional) laser and a variety of procedure specific tools to thermally ablate target tissue in-situ. | Procedure or surgery | LITT with Radiation and Temozolomide |
| Radiation therapyAlso: 3D-Conformal radiation therapy (RT), Intensity Modulated RTOne treatment of 2 Gy will be given daily 5 days per week for a total of 60 Gy over 6 weeks. All portals shall be treated during each treatment session. Doses are specified such that at least 95% of the planning target volume (PTV) shall receive 100% of the prescribed dose. | Radiation | LITT with Radiation and Temozolomide |
| TemozolomideTemozolomide will be administered continuously from day 1 of radiotherapy to the last day of radiation at a daily oral dose of 75 mg/m2 for a maximum of 49 days | Drug | LITT with Radiation and Temozolomide |
Primary outcome
Study safety as determined by the number of patients who experience pre-specified adverse events
Time frame: Up to 12 weeks after LITT therapy
pre-specified adverse events include: Wound dehiscence, grade 3 (CTCAE v4.0), Grade 3 Seizures (CTCAE v4.0) in patients without a prior history of seizures and on adequate anti-seizure medications, Cerebral edema, grade 4 (CTCAE v4.0), Failure to complete of 60 Gy radiation
1 secondary outcome
Number of patients with adjustments to radiation plan to account for post-LITT tissue distortion
Time frame: Up to 12 weeks after LITT therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
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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.
Jennifer Yu, MD, PhD principal investigator
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing LITT, Radiation therapy and Temozolomide in people with High Grade Glioma, run by Case Comprehensive Cancer Center at 1 site in United States.
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 13 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: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Study safety as determined by the number of patients who experience pre-specified adverse events (time frame: Up to 12 weeks after LITT therapy). 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 6 Aug 2026.