LITT Followed by Hypofractionated RT for Recurrent Gliomas

  • STATUS
    Recruiting
  • End date
    Feb 25, 2023
  • participants needed
    32
  • sponsor
    University of Maryland, Baltimore
Updated on 25 January 2021
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 Cancer, Glioma, Glioblastoma Multiforme, Malignant neoplasm of brain, Cancer/Tumors, Brain Tumor (Pediatric), Ewing's Family Tumors, Cancer (Pediatric), Brain Cancer, Gliomas, Neoplasms, Brain Tumor, glioblastoma, glial tumor, brain tumors
Treatment Procedure: LITT, Hypo-Fractionated Radiation Therapy
Clinical Study IdentifierNCT04181684
SponsorUniversity of Maryland, Baltimore
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 22 yrs?
Gender: Male or Female
Do you have any of these conditions: Gliomas or Glioma or Cancer (Pediatric) or Neoplasms or Malignant neoplasm of brain or Brain Tumor or Cancer/Tumors or Cancer or Ewing's Family Tumors...?
Do you have any of these conditions: Cancer/Tumors or Brain Tumor or Glioblastoma Multiforme or Cancer or Malignant neoplasm of brain or Brain Tumor (Pediatric) or Cancer (Pediatric) or E...?
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
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