Expedited Laser Interstitial Thermal Therapy + Chemoradiation For Newly Diagnosed High Grade Gliomas (NCT02970448) | Clinical Trial Compass
CompletedEarly Phase 1
Expedited Laser Interstitial Thermal Therapy + Chemoradiation For Newly Diagnosed High Grade Gliomas
United States13 participantsStarted 2017-08-24
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Study safety as determined by the number of patients who experience pre-specified adverse events