leptomeningeal metastasis
Conditions
Interventions
Group 1:Concurrent brain radiotherapy with intra-Ommaya reservoir pemetrexed administration
Group 2:Sequential brain radiotherapy followed by intra-Ommaya reservoir pemetrexed administration
Group 3:Sequential intra-Ommaya reservoir pemetrexed administration followed by brain radiotherapy
Sponsors
Fifth Affiliated Hospital, Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary participation in the clinical study and signing of the informed consent form (ICF); 2. Age between 18 and 75 years, regardless of gender; 3. Histologically confirmed stage IV (according to the AJCC TNM staging system, 8th edition) lung adenocarcinoma; 4. Presence of disease that is unresectable and not amenable to curative-intent concurrent chemoradiotherapy; 5. Diagnosis of leptomeningeal metastasis based on the NCCN and EANO-ESMO guidelines, including: patients with leptomeningeal metastasis confirmed by cerebrospinal fluid cytology or leptomeningeal histopathology (Type I), or patients with clinical symptoms or contrast-enhanced cranial MRI findings consistent with leptomeningeal metastasis (Type II); 6. Ability to provide a tumor genetic testing report, or to provide tumor tissue samples for such testing; 7. ECOG performance status score of 0–3; KPS score >= 50; 8. Organ function levels must meet the following criteria: Hematology: absolute neutrophil count >= 1.5 × 10?/L, platelet count >= 80 × 10?/L, hemoglobin >= 90 g/L; Liver function: total bilirubin = 50 mL/min; Coagulation function: INR, PT, and APTT <= 1.5 × ULN; Essentially normal electrocardiogram.
Exclusion criteria
Exclusion criteria: 1. Presence of other invasive malignancies, with the exception of cured basal cell carcinoma or squamous cell carcinoma of the skin, carcinoma in situ (e.g., breast carcinoma in situ, cervical carcinoma in situ), superficial bladder cancer, or malignancies that have remained recurrence-free and without treatment for the past 2 years; 2. Presence of serious comorbidities, such as peptic ulcer with bleeding, intestinal obstruction, acute heart failure, severe arrhythmia, acute myocardial infarction, stroke, or acute renal failure; 3. History of encephalitis, multiple sclerosis, or central nervous system infection; 4. Prior receipt of intrathecal pemetrexed, whole-brain radiotherapy, or implantation of an Ommaya reservoir or ventriculoperitoneal shunt; 5. Presence of severe coagulation disorders or bleeding tendencies; 6. History of hypersensitivity to pemetrexed; 7. Severe psychiatric abnormalities or extreme non-cooperation, such as refractory epilepsy; 8. Moderate to severe coma or a Glasgow Coma Scale score < 9; 9. Active and/or uncontrolled infections, including tuberculosis, human immunodeficiency virus (HIV), and syphilis; 10. Receipt of treatment with other investigational drugs or devices not yet approved for marketing within 4 weeks prior to the start of the clinical trial; 11. Failure to recover from prior antitumor therapy-related adverse events to = Grade 1 per CTCAE Version 5 (with the exception of toxicities deemed by the investigator to pose no safety risk, such as alopecia or Grade 2 chemotherapy-induced neurotoxicity); 12. The investigator considers that the subject presents with other serious systemic diseases or other conditions that render them unsuitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival time (OS);Objective response rate of the nervous system (NORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Control rate of neurological disorders (NDCR);Neurological progression-free survival period (NPFS);Progression-free survival rate at 6 months (NPFS6m);3-month, 6-month, 9-month and 12-month overall survival rates;Adverse event (AE); | — |
Countries
China
Contacts
Public ContactZibin Liang
Fifth Affiliated Hospital, Sun Yat-Sen University
Outcome results
None listed