NCT06716775Not yet recruiting
Tumor Treating Fields (TTF) in Combination with Stereotactic Radiosurgery(SRS) for Brain Metastases from Non-small Cell Lung Cancer.
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.
Source: ClinicalTrials.gov · Last updated 4 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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) .
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 29 Nov 2024
- Start date
- 20 Dec 2024
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Jiangsu Healthy Life Innovation Medical Technology Co., Ltd
- Diseases
- Lung cancer
- NCT number
- NCT06716775
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 20 Dec 2024 to the primary completion date, 30 Jun 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- There were infection, ulcer and unhealed wound in the skin where the electrode was applied；
- Patients allergic to conductive hydrogels or medical adhesives;
Lab values
- 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;
- 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);
Other
- Positive driver genes;
- Recurrent brain metastasis of NSCLC;
- Suffering from severe cerebral edema;
- Leptomeningeal metastases;
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.