LITT Palliative Treatment for Patients With Malignant Gliomas

Withdrawn before enrolling

Conditions studied: Malignant Glioma of Brain, Glioblastoma

In brief

The purpose of this study is to to describe the effect of a palliative regimen consisting of Laser Interstitial Thermal Therapy (LITT) on distress, quality of life (QOL), neurocognition, days in the hospital, patient disposition, and readmission in newly diagnosed World Health Organization (WHO) grade IV malignant glioma (glioblastoma (GBM) or gliosarcoma) patients unable to undergo broader surgical resection. The primary objective is to assess changes in the National Comprehensive Cancer Network (NCCN) distress thermometer in newly diagnosed WHO grade IV malignant glioma patients who receive LITT. \*Please note: This study was originally designed as a interventional device study studying the effect of the LITT procedure; however, it was re-designed as an observational study in which the patient population being studied is approved to receive the LITT procedure.

Key facts

Study ID

NCT03176160

Run by

Duke University

People needed

0

Starts

2019-06-01

Expected to finish

2022-06-01

Last updated by the study team

2019-02-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient with histopathologically confirmed newly diagnosed WHO grade IV malignant glioma (GBM or gliosarcoma, multifocal disease is allowed) unable to undergo surgical resection, who is approved and scheduled to receive the LITT procedure by the treating neurosurgeon
• ≥18 years of age
• Patient is "fragile" (age 18-69, KPS 50-70), "elderly" (age > 69, KPS 80-100), or "elderly and fragile" (age > 69, KPS 50-70)
• Patient must not have received prior chemotherapy or brain radiotherapy
• Patient is able and willing to complete the QOL and neurocognitive questionnaires. Inability (illiteracy, loss of sight, or other equivalent reason) to complete the questionnaires will not make the patient ineligible for the study. If patients are not able to read or write, proxy interviews will be conducted in-person or via telephone by the assigned study clinician or study team member (Trail-Making A \& B will not be performed on these patients).
• Patient consent must be obtained according to Duke institutional policy
• Patient must be accessible for follow-up

You may not qualify if…

• Non-English speaking or inability to read and understand English
• Patients with concurrent malignancies requiring active treatment, except: non-melanoma skin cancer, or in-situ cancer of the cervix.
• Patients with a serious active infection or other serious underlying medical conditions that would impair the ability of the patient to complete the protocol-related QOL and distress questionnaires and cognition assessments

Where it is running

• The Preston Robert Tisch Brain Tumor Center at Duke — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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