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

NCT02970448 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2025-06-19

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Jennifer Yu, MD, PhD · Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-24
Primary Completion
2023-11-10
Completion
2024-10-25
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02970448 on ClinicalTrials.gov