Pilot Study of Laser Interstitial Thermal Therapy Followed By Hypofractionated Radiation Therapy for Treatment of Recurrent Gliomas. (GCCC 19140)

STATUS

Recruiting
days left to enroll

27
participants needed

32
sponsor

University of Maryland, Baltimore

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Updated on 28 October 2022

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karnofsky performance status

treatment regimen

MRI

brain mri

recurrent tumor

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.

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.

Details

Condition	Glioblastoma, Brain Tumor, Glioma, Neoplasms
Treatment	Procedure: LITT, Hypo-Fractionated Radiation Therapy
Clinical Study Identifier	NCT04181684
Sponsor	University of Maryland, Baltimore
Last Modified on	28 October 2022

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Eligibility		Yes	No	Not Sure
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
	History and physical including neurological exam within 30 days prior to registration
	within 60 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

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Pilot Study of Laser Interstitial Thermal Therapy Followed By Hypofractionated Radiation Therapy for Treatment of Recurrent Gliomas. (GCCC 19140)