LITT Palliative Treatment for Patients With Malignant Gliomas
| Status: | Withdrawn |
|---|---|
| Conditions: | Brain Cancer, Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/1/2019 |
| Start Date: | June 2019 |
| End Date: | June 2022 |
Laser Interstitial Thermal Therapy (LITT) as Palliative Treatment for Patients With Malignant Glioma Requiring Standard Treatment Alternatives
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.
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.
Patients will be identified from those previously approved for the LITT procedure. Following
consent, 20 patients will complete NCCN distress, Quality of Life (QOL) and neuro-cognitive
baseline testing, followed by the LITT procedure using the NeuroBlate® System (NBS) and
intra-operative magnetic resonance imaging (MRI). Per standard clinical practice, after
completing LITT, patients will undergo radiation at the discretion of the treating radiation
oncologist. Patients will likewise receive concomitant and adjuvant chemotherapy (typically
temozolomide) at the discretion of the treating neuro-oncologist. All patients will complete
NCCN distress, QOL and neurocognitive testing immediately after the LITT procedure on
post-operative day 1 as able, or immediately prior to discharge if more appropriate.
Additionally, they will complete these same tests approximately 1, 3, 6, 12, and 24 months
after the completion of LITT therapy.
consent, 20 patients will complete NCCN distress, Quality of Life (QOL) and neuro-cognitive
baseline testing, followed by the LITT procedure using the NeuroBlate® System (NBS) and
intra-operative magnetic resonance imaging (MRI). Per standard clinical practice, after
completing LITT, patients will undergo radiation at the discretion of the treating radiation
oncologist. Patients will likewise receive concomitant and adjuvant chemotherapy (typically
temozolomide) at the discretion of the treating neuro-oncologist. All patients will complete
NCCN distress, QOL and neurocognitive testing immediately after the LITT procedure on
post-operative day 1 as able, or immediately prior to discharge if more appropriate.
Additionally, they will complete these same tests approximately 1, 3, 6, 12, and 24 months
after the completion of LITT therapy.
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
We found this trial at
1
site
Durham, North Carolina 27710
Principal Investigator: Peter Fecci, MD, PhD
Phone: 919-681-8977
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