Concurrent Intrathecal-pemetrexed and Involved-field Radiotherapy for Leptomeningeal Metastasis From Solid Tumors
Status:
Completed
Trial end date:
2019-07-30
Target enrollment:
Participant gender:
Summary
Intrathecal chemotherapy is one of the most important treatment modalities for leptomeningeal
metastasis of solid tumors. In the previous retrospective study, it has been proved that
concurrent radiotherapy and intrathecal methotrexate for leptomeningeal metastasis from solid
tumors with adverse prognostic factors showed great effectiveness and safety. The preliminary
results of investigators' current prospective clinical study (Involved-field Radiotherapy
Combined With Concurrent Intrathecal-methotrexate Versus Intrathecal-Ara-C for Leptomeningeal
Metastases From Solid Tumor: A Randomized Phase II Clinical Trial. ClinicalTrials.gov
identification number: NCT03082144) also showed that the regimen of concurrent intrathecal
chemotherapy and radiotherapy may serve as an optimal therapeutic option for treatment of
leptomeningeal metastases from solid tumors. Pemetrexed is a newer multitargeted antifolate
which has shown activity in various tumors. In investigators' current study (Intrathecal
Pemetrexed for Recurrent Leptomeningeal Metastasis From Non-small Cell Lung Cancer: A
Prospective Pilot Clinical Trial. ClinicalTrials.gov identification number: NCT03101579), the
regimen of intrathecal pemetrexed with folic acid and vitamin B12 supplementation may provide
higher effectiveness and safety for recurrent leptomeningeal metastasis from non-small cell
lung cancer. Therefore, the purpose of the study is to evaluate the tolerability, safety and
effectiveness of intrathecal pemetrexed combined with involved-field radiotherapy as the
first line treatment in patients with leptomeningeal metastases from malignant solid tumors.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
First Hospital of Jilin University The First Hospital of Jilin University