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Procedure

LITT + Chemoradiation for Brain Tumor

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%

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 weeks after litt therapy

Awards & highlights

No Placebo-Only Group

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.

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.

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

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had severe brain swelling before surgery.

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I've had surgery complications affecting my daily activities or making me unfit for further cancer treatment.

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My brain tumor has come back and is high grade.

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I am not pregnant and willing to use birth control during the study.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1880