Expedited Laser Interstitial Thermal Therapy + Chemoradiation For Newly Diagnosed High Grade Gliomas

High Grade Glioma Clinical Trial

Official title: Expedited Laser Interstitial Thermal Therapy and Chemoradiation for Patients With Newly Diagnosed High Grade Gliomas

Status Recruiting

Clinical Trial Summary

The investigators of this study want to see if shortening the total treatment time for brain tumors is safe.The treatment for participant's brain tumors is laser surgery (Laser Interstitial Thermal Therapy (LITT)) followed by radiation with chemotherapy. For participants, the total time of treatment from surgery to the end of radiation and chemotherapy is about l 0 weeks long. This study asks whether it is safe to shorten the total treatment to 7 weeks.

To shorten the total treatment time, investigators want to see if it is safe to start radiation with chemotherapy within 5 days after surgery. Usually patients start their radiation with chemotherapy about 21-28 days after the surgery.

Shortening the total time of treatment may allow investigators to kill the cancer cells more effectively.

Clinical Trial Description

Primary Objective To determine the safety and feasibility of reducing the time interval between LITT and the start of chemoradiation to ≤ 7 days.

The primary endpoint (binary) for safety/feasibility will be defined as the occurrence of one or more of the following within each patient during a window of observation from the completion LITT to the end of radiation:

• Wound dehiscence, grade 3 {CTCAE v4.0)

• Seizures, grade 3 (CTCAE v4.0) in patients without a prior history of seizures and on adequate anti-seizure medications

• Cerebral edema, grade 4 (CTCAE v4.0)

• Failure to complete of 60 Grays (Gy) of radiation

Secondary Objective(s) To estimate the proportion of patients requiring adjustments in radiation plans post-LITT.

Secondary Endpoint: Requirement of an adjustment in the radiation plan to account for post-LITT tissue distortion.

Study design This study will be a 2-stage, single-institution safety and feasibility trial. Patients will be evaluated by a neuro-oncology team consisting of a neurosurgeon trained in LITT, radiation oncologist and medical oncologist prior to surgery. Evaluable patients will have a histologic diagnosis of high-grade glioma, complete LITT, and are candidates for standard concurrent radiation (60 Gy) and temozolomide as determined by the treating physician. Concurrent chemoradiation will begin within 7 days of the LITT procedure. ;

Related Conditions & MeSH terms

• Glioma
• High Grade Glioma

• NCT number: NCT02970448
• Study type: Interventional
• Source: Case Comprehensive Cancer Center
• Contact: Jennifer Yu, MD, PhD
• Phone: 1-866-223-8100
• Email: TaussigResearch@ccf.org
• Status: Recruiting
• Phase: Early Phase 1
• Start date: August 24, 2017
• Completion date: June 1, 2024