Status:
UNKNOWN
Intra-pemetrexed Alone or Combined With Concurrent Radiotherapy for Leptomeningeal Metastasis
Lead Sponsor:
The First Hospital of Jilin University
Collaborating Sponsors:
The Second Hospital of Hebei Medical University
Second Affiliated Hospital of Guangzhou Medical University
Conditions:
Leptomeningeal Metastasis
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Intrathecal chemotherapy is one of the mainstay treatment options for leptomeningeal metastases. Owing to the limited number of agents available for intrathecal chemotherapy, it is crucial to find a n...
Detailed Description
In this randomized, open-label, multicenter clinical trial, we aim to compare the efficacy and safety of intrathecal pemetrexed combined with concomitant involved-field radiation therapy and intrathec...
Eligibility Criteria
Inclusion
- Patients with a confirmed or probable diagnosis of leptomeningeal metastasis according to European Association of Neuro-Oncology-European Society for Medical Oncology (EANO-ESMO) guidelines；Patients who have been definitely diagnosed as leptomeningeal metastasis according to cerebrospinal fluid cytology, or patients who got the clinical diagnosis by combining with neuroimaging, history of cancer, clinical manifestation, cerebrospinal fluid examination, etc.
- Participants with histologically or cytologically confirmed disease from solid tumors;
- No history of whole brain radiotherapy;
- Normal liver and kidney function; WBC≥4000/mm3, Plt≥100000/mm3.
Exclusion
- Patients with primary tumor of hematological tumors or primary central germ cell tumors;
- Patients administrated with new molecular targeted therapy which is effective for leptomeningeal metastasis in 2 weeks;
- Patients with hydrocephalus or other factors suggestive of cerebrospinal fluid circulation obstruction;
- Patients with severe encephalopathy, grade 3 leukoencephalopathy, Glasgow Coma Scale less than 8 score;
- Patients with extensive and lethal systemic diseases with few treatment options;
- Patients with poor compliance, or for other reasons, the researchers considered unsuitable to participate in this clinical study.
Key Trial Info
Start Date :
August 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05305885
Start Date
August 19 2022
End Date
July 1 2024
Last Update
September 30 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The First Hospital of Jilin University
Changchun, Jilin, China, 130021