NCT02970448

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

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• High Grade Glioma

Interventions

Type	Name	Description
PROCEDURE	LITT	MRI-guided laser interstitial thermal therapy uses a gas cooled side-firing (directional) laser and a variety of procedure specific tools to thermally ablate target tissue in-situ.
RADIATION	Radiation therapy	One treatment of 2 Gy will be given daily 5 days per week for a total of 60 Gy over 6 weeks. All portals shall be treated during each treatment session. Doses are specified such that at least 95% of the planning target volume (PTV) shall receive 100% of the prescribed dose.
DRUG	Temozolomide	Temozolomide will be administered continuously from day 1 of radiotherapy to the last day of radiation at a daily oral dose of 75 mg/m2 for a maximum of 49 days

Timeline

• Start date: 2017-08-24
• Primary completion: 2023-11-10
• Completion: 2024-10-25
• First posted: 2016-11-22
• Last updated: 2025-06-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study