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NCT Number: NCT06716775

Tumor Treating Fields (TTF) in Combination with Stereotactic Radiosurgery(SRS) for Brain Metastases from Non-small Cell Lung Cancer.

This is a randomized, controlled, open-label, phase III trials. The main purpose of this study is to evaluate the effectiveness and safety of tumor treating felds (TTF) combined with stereotactic radiosurgery (SRS) in the treatment of brain metastases from non-small cell lung cancer (NSCLC) .

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The age of the subject was between 18 and 75 years old (inclusive), regardless of gender;
  • The predicted survival time was ≥3 months;
  • Newly diagnosed with NSCLC brain metastasis;
  • MRI imaging showed 1-10 unresectable brain metastases;
  • Karnofsky performance status (KPS) score ≥70;
  • Able to operate the TTF independently or with the help of a caregiver;
  • Subjects of childbearing potential had to agree to use effective contraception for the duration of the trial;
  • Voluntarily signed the informed consent form.

Exclusion criteria

  • Positive driver genes;
  • Recurrent brain metastasis of NSCLC;
  • Suffering from severe cerebral edema;
  • Leptomeningeal metastases;
  • Participants had to meet certain criteria for bone marrow, liver and kidney function before enrollment, and were not eligible if they had any of the following:
  • platelet count < 100×103/μL;
  • absolute neutrophil count < 1.5×103/μL;

d. AST or ALT exceeding 2.5 times the upper limit of normal; c.Total bilirubin more than 1.5 times the upper limit of the normal range; d.Severe renal impairment (serum creatinine >1.7 mg/dL, or >150 μmol/L);

  • There were infection, ulcer and unhealed wound in the skin where the electrode was applied;
  • Patients allergic to conductive hydrogels or medical adhesives;
  • Those who are pregnant or preparing to become pregnant or who are breastfeeding;
  • Patients with poor compliance, as judged by the investigator, or other factors considered by the investigator to be not suitable for the study.

Treatment and study plan

Tumor treating felds (TTF)

Device

Tumor Treating Fields will be administered continuously with a planned ≥ 18 h per day.

Best Standard of Care

Other

Patients will be treated with the best known standard of care for NSCLC brain metastasis and undergo SRS alone.

Primary outcomes

  1. Intracranial tumor progression-free survival (iPFS)

    Time frame: 3 years

    Defined as the time from randomization to the first occurrence of intracranial progression (according to RANO-BM criteria) or neurologic death, whichever occurred first.

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: 3 years

    Defined as the time from the date of treatment until death due to any cause.

  2. Objective response rate (ORR)

    Time frame: 3 years

    Defined as the number (%) of patients with at least 1 visit response of complete response (CR) or partial response (PR).

  3. Time to neurocognitive failure

    Time frame: 3 years

  4. Rate of intracranial progression at 2, 4, 6, 8, 10, 12 months

    Time frame: 3 years

  5. Neurocognitive failure-free survival

    Time frame: 3 years

  6. Rate of decline in cognitive function

    Time frame: 3 years

  7. Number of participants with adverse events (AEs)

    Time frame: 3 years

    Adverse events will be defined as the incidence, frequency and severity of adverse events (AEs) noted in patients treated with study treatments

Study contacts

Contact information is provided by the study sponsor or research team.

Ligang Xing Dr Xing, Doctor

CONTACT

[email protected]

(0531)87984777

Sponsors and collaborators

Lead sponsor

Jiangsu Healthy Life Innovation Medical Technology Co., Ltd

Industry

Collaborators

  • Shandong Cancer Hospital and Institute

Registry information

Official study title

Tumor Treating Fields (TTF) in Combination with Stereotactic Radiosurgery(SRS) for Brain Metastases from Non-small Cell Lung Cancer: a Randomized, Controlled, Open-label Study.

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Dec 4, 2024
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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