LITT Followed by Hypofractionated RT for Recurrent Gliomas
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Procedure: LITT, Hypo-Fractionated Radiation Therapy.
- Who it may be relevant to
- Registry conditions: Glioblastoma, Brain Tumor, Glioma, Neoplasms. Basic parameters: from 22 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pilot Study of Laser Interstitial Thermal Therapy Followed By Hypofractionated Radiation Therapy for Treatment of Recurrent Gliomas.
Overview
The purpose of this study is to evaluate the treatment regimen of using Laser Interstitial Thermal Therapy (LITT) and Hypo-fractionated Radiation Therapy to treat patients with recurrent gliomas.
Detailed description
Radiation therapy is preferably used as an adjunct to surgery for patients with a newly diagnosed or recurrent glioblastoma. LITT offers an alternative to surgical resection, and due to its minimally invasive nature, does not delay initiating radiation therapy. Another advantage of LITT prior to radiation therapy is the ability to obtain a tissue diagnosis of recurrent tumor prior to initiating radiation therapy.
Interventions
- Device Procedure: LITT
This procedure is done under MRI guidance and employs low-powered thermal energy to achieve tumor ablation through coagulation. - Radiation Hypo-Fractionated Radiation Therapy
Treatments will be delivered once daily on consecutive treatment days (typically 5 fractions per week). Radiation therapy simulation is to be performed within 10 days of the LITT procedure.
Primary outcome measures
- Adverse Events [Time frame: 2 years]
Secondary outcome measures (6)
- Progression-free survival at 6 months [Time frame: 2 Years]
- Median progression-free survival [Time frame: 2 Years]
- Median overall survival [Time frame: 2 years]
- 1-year overall survival [Time frame: 2 years]
- Overall response rate [Time frame: 2 years]
- Quality of Life before, during, and after treatment [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- Patients with history of a WHO Grade II-IV glioma with radiographic evidence of recurrent or progressive tumor
- Patient must have received prior radiation therapy for initial treatment of glioma
- Patients with any number of recurrences are allowed as long as the patient has not undergone re-irradiation
- Brain MRI with contrast demonstrates an enhancing tumor ≤ 6 cm in largest diameter within 60 days prior to registration
- History and physical including neurological exam within 30 days prior to registration
- Karnofsky performance status ≥ 60% within 30 days prior to registration
- Age ≥ 22 years old
- Minimum interval since completion of prior radiation treatment is 8 weeks
- Patients will only receive re-irradiation if pathology from LITT is consistent with recurrent tumor
- Patients must have signed an approved informed consent
- Patients with the potential for pregnancy or impregnating their partner must agree to practice effective contraceptive methods to avoid conception while on study and for 6 months after study completion.
- Female patients of child-bearing potential must have a negative pregnancy test within 28 days prior to study registration.
Exclusion criteria
- Patients that are not surgical candidates for stereotactic biopsy or laser ablation
- Patients with impaired cardiac function or clinically significant cardiac diseases, including any of the following:
- History or presence of serious uncontrolled ventricular or significant arrhythmias.
- Any of the following within 6 months prior to registration: myocardial infarction, severe/unstable angina, coronary artery bypass graft, congestive heart failure, cerebrovascular accident, transient ischemic attack , pulmonary embolism
- Infratentorial tumor or evidence of leptomeningeal spread
- Inability to undergo a MRI
- Pregnant or breast-feeding women
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 4 centers
- University of Maryland Greenebaum Cancer Center — Baltimore
- UCH Kaufman Cancer Center — Bel Air
- Central Maryland Radiation Oncology — Columbia
- Baltimore Washington Medical Center — Glen Burnie
Identifiers
NCT: NCT04181684 · HP-00088569