Pilot Study of Laser Interstitial Thermal Therapy Followed By Hypofractionated Radiation Therapy for Treatment of Recurrent Gliomas.
Overview
- Phase
- Not Applicable
- Intervention
- Procedure: LITT
- Conditions
- Glioblastoma
- Sponsor
- University of Maryland, Baltimore
- Enrollment
- 32
- Locations
- 4
- Primary Endpoint
- Adverse Events
- Status
- Recruiting
- Last Updated
- 3 months ago
Overview
Brief Summary
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.
Investigators
Department of Radiation Oncology
Principal Investigator
University of Maryland, Baltimore
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
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
Arms & Interventions
Experimental: LITT with Hypofractionated radiation therapy
Laser interstitial thermal therapy (LITT) followed by hypo-fractionated radiation therapy, 35Gy/10 fractions.
Intervention: Procedure: LITT
Experimental: LITT with Hypofractionated radiation therapy
Laser interstitial thermal therapy (LITT) followed by hypo-fractionated radiation therapy, 35Gy/10 fractions.
Intervention: Hypo-Fractionated Radiation Therapy
Outcomes
Primary Outcomes
Adverse Events
Time Frame: 2 years
To complete protocol treatment without undue treatment-related acute toxicity in recurrent or progressive glioma subjects undergoing LITT followed by hypofractionated radiation therapy.
Secondary Outcomes
- Median progression-free survival(2 Years)
- Median overall survival(2 years)
- Progression-free survival at 6 months(2 Years)
- Overall response rate(2 years)
- Quality of Life before, during, and after treatment(2 years)
- 1-year overall survival(2 years)