LITT Followed by Hypofractionated RT for Recurrent Gliomas

Not Applicable

Recruiting

• Conditions: Glioma; Neoplasms; Glioblastoma; Brain Tumor
• Interventions: Radiation: Hypo-Fractionated Radiation Therapy

• Registration Number: NCT04181684
• Lead Sponsor: University of Maryland, Baltimore

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.

Study Timeline

• Study First Submitted: 2019-11-24
• Study First Submitted QC: 2019-11-26
• Study First Posted: 2019-11-29
• Study Start: 2020-01-08
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-07
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. 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

2. Brain MRI with contrast demonstrates an enhancing tumor ≤ 6 cm in largest diameter within 60 days prior to registration

3. History and physical including neurological exam within 30 days prior to registration

4. Karnofsky performance status ≥ 60% within 30 days prior to registration

5. Age ≥ 22 years old

6. 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

7. Patients must have signed an approved informed consent

8. 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.

9. Female patients of child-bearing potential must have a negative pregnancy test within 28 days prior to study registration.

Exclusion Criteria

1. Patients that are not surgical candidates for stereotactic biopsy or laser ablation

2. 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

3. Infratentorial tumor or evidence of leptomeningeal spread

4. Inability to undergo a MRI

5. Pregnant or breast-feeding women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental: LITT with Hypofractionated radiation therapy	Hypo-Fractionated Radiation Therapy	Laser interstitial thermal therapy (LITT) followed by hypo-fractionated radiation therapy, 35Gy/10 fractions.

Primary Outcome Measures

Name	Time	Method
Adverse Events	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 Outcome Measures

Name	Time	Method
Median progression-free survival	2 Years	To describe median progression-free survival rate in subjects with recurrent or progressive gliomas treated with Laser Interstitial Thermal Therapy followed by hypofractionated radiation therapy.
Median overall survival	2 years	To describe median progression-free survival rate in subjects with recurrent or progressive gliomas treated with Laser Interstitial Thermal Therapy followed by hypofractionated radiation therapy.
Progression-free survival at 6 months	2 Years	To describe progression-free survival rate in subjects with recurrent or progressive gliomas treated with Laser Interstitial Thermal Therapy
Overall response rate	2 years	To describe overall response survival rate in subjects with recurrent or progressive gliomas treated with Laser Interstitial Thermal Therapy followed by hypofractionated radiation therapy.
Quality of Life before, during, and after treatment	2 years	Patient reported quality of life impact from undergoing LITT followed by hypofractionated radiation therapy using the M.D. Anderson Symptom Inventory- Brain Tumor (MDASI-BT) questionnaire.
1-year overall survival	2 years	To describe 1 year overall survival rate in subjects with recurrent or progressive gliomas treated with Laser Interstitial Thermal Therapy followed by hypofractionated radiation therapy.

Trial Locations

Locations (4)

University of Maryland Greenebaum Cancer Center; 🇺🇸 Baltimore, Maryland, United States

UCH Kaufman Cancer Center; 🇺🇸 Bel Air, Maryland, United States

Central Maryland Radiation Oncology; 🇺🇸 Columbia, Maryland, United States

Baltimore Washington Medical Center; 🇺🇸 Glen Burnie, Maryland, United States