Clinical trial · Observational
LITT Palliative Treatment for Patients With Malignant Gliomas
Laser Interstitial Thermal Therapy (LITT) as Palliative Treatment for Patients With Malignant Glioma Requiring Standard Treatment Alternatives
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Failure to enroll
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Malignant Glioma of Brain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Palliative regimen consisting of LITT | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients receiving palliative regimen consisting of LITT
- description
- Patients with WHO grade IV malignant glioma who are approved for and receive the LITT (Laser Interstitial Thermal Therapy) procedure
- interventionNames
- Other: Palliative regimen consisting of LITT
Primary outcomes (1)
- measure
- Change in NCCN distress thermometer score
- timeFrame
- Up to 24 months after the LITT procedure
- description
- Mean change from baseline in the NCCN distress thermometer score
Secondary outcomes (2)
- measure
- Median overall survival
- timeFrame
- 24 months after LITT
- description
- Overall survival will be defined as the time in months between Laser Interstitial Thermal Therapy (LITT) and death, or last follow-up if alive. Kaplan-Meier methods will be used to estimate overall survival.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available