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LITT Combined With Early Use of Temozolomide for Recurrent Glioblastomas

Sponsor
Beijing Tiantan Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05663125
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
25
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to investigate the safety and efficacy of Laser Interstitial Thermal Therapy (LITT) combined with postoperative early use of temozolomide in treating recurrent glioblastomas.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Detailed Description

This is an open-label, non-randomized Phase II study, planning to recruit about ten patients.

The primary objective of this study is to investigate the safety of MRI-guided LITT in combination with the early application of temozolomide.

The secondary outcome is to explore the efficacy of MRI-guided LITT combined with the early use of temozolomide in treating recurrent glioblastomas.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Safety and Efficacy of LITT Combined With Early Use of Temozolomide for Recurrent Glioblastomas
Actual Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: LITT with Early Application of Temozolomide

Patients will receive the early use of temozolomide sooner after Laser interstitial thermal therapy (LITT).

Procedure: Laser interstitial thermal therapy
Ablation of the tumor will be done by MRI-guided laser interstitial thermal therapy with the assistance of neuro-navigation.
Other Names:
  • LITT

    • Drug: Temozolomide
    Temozolomide will be administered continuously from the 1st to the 21st day after LITT surgery. The oral dose of temozolomide is 75 mg/m2. And then, it will be given at a routine dose from the second month after surgery.
    Other Names:
  • TMZ

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Adverse Events [From Day 1 throughout the study until 3 months]

      To complete protocol treatment without undue treatment-related acute toxicity in recurrent glioblastoma patients undergoing LITT followed by early use of temozolomide.

    Secondary Outcome Measures

    1. Time to Progression (TTP) [12 months]

      TTP, defined as time from LITT to recorded tumor progression

    2. Overall survival (OS) [18 months]

      OS, defined as time from diagnosis to death

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Imaging (PET-MRI) indicates tumor progression or recurrence

    2. Patient ≥18 years old

    3. The tumor was the first-time recurrence

    4. The pathology of the tumor is glioblastoma (IDH wild-type, WHO grade 4)

    5. MRI indicated a single tumor or multiple tumors with visual enhancement =<3cm

    6. Maximum tumor diameter: single tumor =<3cm; Multiple tumors, targeted lesion =<3cm

    7. Single tumor or one of the multiple tumor lesions involved deep functional areas such as the insula lobe or thalamus

    8. KPS score >=60 within 30 days before treatment

    9. No serious liver or kidney dysfunction

    10. Patients must be able to understand how to sign the informed consent document

    Exclusion Criteria:

    1. The tumor crossed the midline or involved bilateral cerebral hemispheres

    2. Inability to perform MRI examination or intolerance to MRI contrast agent

    3. There is an active infection of the patient

    4. The patient had abnormal coagulation function

    5. Imaging before treatment indicated signs of cerebral hernia or midline displacement > 1.0cm

    6. The patient received radiotherapy, chemotherapy (including immunotherapy), or other therapeutic measures after tumor recurrence

    7. Patients who have participated in clinical trials of any other drug or medical device within three months of the screening.

    8. KPS score =<50 points

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing Tiantan Hospital Beijing China

    Sponsors and Collaborators

    • Beijing Tiantan Hospital

    Investigators

    • Principal Investigator: Dabiao Zhou, MD, Beijing Tiantan Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dabiao Zhou, MD, Clinical Professor, Beijing Tiantan Hospital
    ClinicalTrials.gov Identifier:
    NCT05663125
    Other Study ID Numbers:
    • KY2022-232-01
    First Posted:
    Dec 23, 2022
    Last Update Posted:
    Dec 23, 2022
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dabiao Zhou, MD, Clinical Professor, Beijing Tiantan Hospital
    GBM
    Glioblastoma
    LITT
    Laser Interstitial Thermal Therapy
    Additional relevant MeSH terms:
    Glioblastoma
    Recurrence
    Temozolomide

    Study Results

    No Results Posted as of Dec 23, 2022