Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:47 AM
Ignite Modification Date:
2025-12-25 @ 4:47 AM
NCT ID:
NCT03626818
Eligibility Criteria:
Inclusion Criteria:
1. Pathologically proven solid tumor malignancy.
2. Brain MRI within 1 month of enrolment, at least three metastatic lesions in the brain (of which at least one had to be measurable according to Response Evaluation Criteria in Solid Tumors \[RECIST\], version 1.1).
3. Males or females aged ≥18 years, \< 75 years.
4. had an Eastern Cooperative Oncology Group (ECOG) performance-status score from 0 to 2.
5. A life expectancy of at least 3 months.
6. Adequate organ function according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0
7. Subjects did not receive other treatments such as cytotoxic drugs, radiotherapy (non-brain metastases) or surgery within 2 weeks.
8. Patients must have ability and general health that permits completion of the study requirements and required follow up.
9. Patients must be willing to complete NCF and QOL assessments at pre-specified time points outlined in the protocol.
10. Signed written informed consent
Exclusion Criteria:
1. Prior radiation therapy to the brain.
2. Radiologically or pathologically confirmed metastases in the spinal cord or meninges.
3. Taking sedatives and hypnotics, phenytoin, carbamazepine, rifampin, and barbiturate.
4. Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, hepatic, renal, or metabolic disease).
5. Subjects suffered from dementia, mental illness and other serious cognitive dysfunction.
6.The patient's brain radiation dose needs to be increased. 7.Inability to comply with protocol or study procedures. 8.A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
9.Pregnant female. 10.Breast-feeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03626818
Study Brief:
Protocol Section:
NCT03626818