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LITT + Chemoradiation for Brain Tumor

Q: What makes this research novel and trailblazing?

Since 2002, LITT has been the focus of various clinical trials. The inaugural study was sponsored by Schering-Plough and encompassed 60 patients. Consequently, this drug received Phase 2 approval for further research. Currently, 205 studies are being conducted in 36 nations with 935 cities hosting these investigations.

Q: For what illnesses is Laser Interstitial Thermal Therapy commonly prescribed?

Laser interstitial thermotherapy has been demonstrated to effectively treat nitrosourea treatment and a host of other ailments such as advance directives, refractory mycosis fungoides, and recalcitrant <a href="https://www.withpower.com/clinical-trials/neuroblastoma">neuroblastoma</a>.

Q: Are there any open application slots for this research endeavor?

Indeed, the clinical trial is still enrolling participants. It was first advertised on August 24th 2017 and has recently been updated on July 25th 2022 according to clinicaltrials.gov.

Q: What is the cut-off amount of participants for this clinical investigation?

Affirmative. Per the information on clinicaltrials.gov, this clinical trial is now recruiting participants with an initial post date of August 24th 2017 and a recent update made in July 25th 2022. 45 subjects will be recruited from one location for the study duration.

Q: Has there been past experimentation with Laser Interstitial Thermal Therapy?

Currently, there are 205 active clinical trials exploring the efficacy of LITT with 23 in Phase 3. While several studies are based out of Seoul, Songpa, 4727 locations worldwide have running investigations into this technology.

Phase < 1

Recruiting

Led By Jennifer Yu, MD, PhD

Research Sponsored by Case Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects must have normal organ and marrow function as defined below: 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

Karnofsky Performance status ≥ 60%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 weeks after litt therapy

Awards & highlights

Study Summary

This trial is testing whether it is safe to start radiation and chemotherapy treatment within 5 days of laser surgery to treat brain tumors, instead of the usual 21-28 days. This may allow for more effective cancer cell killing.

Who is the study for?

This trial is for adults with newly diagnosed high-grade gliomas who haven't had previous treatments. They must be in good enough health to undergo surgery, have a certain level of physical function (Karnofsky Performance status ≥ 60%), and have normal organ/marrow function. Women must not be pregnant and participants must agree to use contraception.Check my eligibility

What is being tested?

The study tests if it's safe to shorten brain tumor treatment by starting radiation and chemotherapy within 5 days after laser surgery (LITT), instead of the usual 21-28 days. The goal is to reduce total treatment time from about 10 weeks to just 7 weeks, potentially improving cancer cell eradication.See study design

What are the potential side effects?

Potential side effects may include those associated with laser surgery, radiation therapy, and Temozolomide such as tissue damage at the surgical site, fatigue, skin irritation from radiation, nausea, low blood counts leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can care for myself but may not be able to do active work.

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I have not received any treatments for my current illness.

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My MRI suggests I might have a severe brain tumor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 weeks after litt therapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 weeks after litt therapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 weeks after litt therapy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Study safety as determined by the number of patients who experience pre-specified adverse events

Secondary outcome measures

Number of patients with adjustments to radiation plan to account for post-LITT tissue distortion

Trial Design

1Treatment groups

Experimental Treatment

Group I: LITT with Radiation and TemozolomideExperimental Treatment3 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation therapy

2013

Completed Phase 3

~2850

Temozolomide

2010

Completed Phase 3

~1930

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor

452 Previous Clinical Trials

31,865 Total Patients Enrolled

Jennifer Yu, MD, PhDPrincipal InvestigatorCleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

1 Previous Clinical Trials

10 Total Patients Enrolled

Media Library

Brain Tumor Clinical Trial 2023: LITT Highlights & Side Effects. Trial Name: NCT02970448 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What makes this research novel and trailblazing?

"Since 2002, LITT has been the focus of various clinical trials. The inaugural study was sponsored by Schering-Plough and encompassed 60 patients. Consequently, this drug received Phase 2 approval for further research. Currently, 205 studies are being conducted in 36 nations with 935 cities hosting these investigations."

Answered by AI

For what illnesses is Laser Interstitial Thermal Therapy commonly prescribed?

"Laser interstitial thermotherapy has been demonstrated to effectively treat nitrosourea treatment and a host of other ailments such as advance directives, refractory mycosis fungoides, and recalcitrant neuroblastoma."

Answered by AI

Are there any open application slots for this research endeavor?

"Indeed, the clinical trial is still enrolling participants. It was first advertised on August 24th 2017 and has recently been updated on July 25th 2022 according to clinicaltrials.gov."

Answered by AI

What is the cut-off amount of participants for this clinical investigation?

"Affirmative. Per the information on clinicaltrials.gov, this clinical trial is now recruiting participants with an initial post date of August 24th 2017 and a recent update made in July 25th 2022. 45 subjects will be recruited from one location for the study duration."

Answered by AI

Has there been past experimentation with Laser Interstitial Thermal Therapy?

"Currently, there are 205 active clinical trials exploring the efficacy of LITT with 23 in Phase 3. While several studies are based out of Seoul, Songpa, 4727 locations worldwide have running investigations into this technology."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Expedited Laser Interstitial Thermal Therapy + Chemoradiation For Newly Diagnosed High Grade Gliomas

2017. "Expedited Laser Interstitial Thermal Therapy + Chemoradiation For Newly Diagnosed High Grade Gliomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02970448.

All > Glioma