Refractory leptomeningeal metastases from lung adenocarcinoma
Conditions
Interventions
Concurrent chemoradiotherapy group:Phase I (induction phase) : 15mg pemetrexed intrathecal chemotherapy
Concurrent chemoradiotherapy stage: pemetrexed intrathecal chemotherapy (30mg Q3W, one cycle), a
At each intrathecal injection of pemetrexed, 5mg of dexamethasone was administered intrathecally. Folic acid tablets 0.4mg were taken orally daily, and vitamin B12 1mg was injected intramusitoneally t
Diffuse type (CSF positive only, contrast-enhanced MRI negative) : DT 24-30Gy/12-17F, 1.8-2Gy/F, 5F/W
Whole brain and whole spinal cord: DT 30.6Gy/17F,1.8Gy/F, 5F/W, local lesions can be boosted to 40
Sponsors
The First Affiliated Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Be over 18 years old (including 18 years old) and under 75 years old (including 75 years old). 2.Eastern Cooperative Oncology Group (ECOG) performance status score 0-2, KPS > =60, the expected survival time is not less than 12 weeks. 3. Patients diagnosed with leptomeningeal metastases (including brain tissue metastases) from lung adenocarcinoma according to the 2023 ELANO-ESMO guideline criteria. 4. Failure of first-line treatment for leptomeningeal metastases: (1) LM was diagnosed during TKI treatment in patients with ROS1 fusion gene, NTRK fusion gene, KRAS G12C mutation, MET amplification or skipping mutation in exon 14, RET fusion gene, HER-2 mutation or BRAF V600 mutation; Or if LM was diagnosed and LM progressed during TKI treatment; (2) Leptomeningeal metastases in patients with T790M mutation treated with TKIs or ALK fusion gene positive NSCLS who failed to respond to third-generation EGFR-TKI inhibitors or second/third generation ALK inhibitors; Patients with leptomeningeal metastasis of NSCLS without T790M mutation but disease progression after the first/second/third generation EGFR-TKI inhibitor treatment; (3) Leptomeningeal metastasis from NSCLS with negative driver genes after failure of first-line treatment. 5. Adequate organ function (neutrophil count > =1500/mm^3, platelet count > =70,000/ mm^3, hemoglobin concentration > =7.0 g/dL, serum total bilirubin concentration = 90% in room air, proteinuria < =1+). 6. The patient's brain parenchymal metastases and peripheral tumor lesions were stable. 7. Understand and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Hiv-positive patients. 2. History of allergy to pemetrexed system chemotherapy and radiotherapy. 3. Severe infection or serious complications such as hemorrhagic peptic ulcer, intestinal obstruction, heart failure, renal failure or poorly controlled diabetes. 4. Failure to comply with the requirements of the test. 5. Pregnancy (confirmed by serum or urinary ß-human chorionic gonadotropin [ß-HCG]) or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the intracranial progression-free survival (iPFS) of intrathecal pemetrexed chemotherapy combined with concurrent radiotherapy followed by long-term intrathecal maintenance chemotherapy in patients with refractory leptomeningeal metastases from lung adenocarcinoma.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival time;Intracranial disease control rate;The value of cerebrospinal fluid tumor markers (CEA, CA199, and CA125) in the assessment of therapeutic efficacy;Safety; | — |
Countries
China
Contacts
Public ContactQingsheng Xu
The First Affiliated Hospital, Zhejiang University School of Medicine
Outcome results
None listed