Can a 7-Week brain tumor treatment beat the standard 10-Week plan?
NCT ID NCT02970448
First seen Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time
Summary
This trial asks whether it is safe to shorten the total treatment time for people with newly diagnosed high-grade gliomas, a type of aggressive brain tumor. The usual plan is laser surgery followed by radiation and chemotherapy, taking about 10 weeks. The study tests starting radiation and chemo just 5 days after surgery, aiming to finish in 7 weeks. The goal is to see if this faster approach is safe and might kill cancer cells more effectively.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Laser interstitial thermal therapy (LITT) followed by radiation therapy and chemotherapy
- What this could lead to
- If successful, this could shorten the overall treatment time for brain tumors, potentially making therapy more effective and less burdensome.
- What could go wrong
- This is an early-phase trial with a small number of participants, so results may not apply broadly. There are risks of side effects from the laser surgery and radiation, such as seizures, swelling, or wound issues.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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13 people
The number who actually took part.
- Started
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Aug 2017
- Finished
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Oct 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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 * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195, United States
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