Concurrent Involved-field Radiotherapy and Intrathecal Chemotherapy for Leptomeningeal Metastases From Solid Tumors
Status:
Completed
Trial end date:
2018-12-30
Target enrollment:
Participant gender:
Summary
It has been proved that concurrent radiotherapy (RT) and intrathecal methotrexate (MTX) for
leptomeningeal metastases (LM) from solid tumors with adverse prognostic factors showed great
effectiveness and safety. Cytarabine(Ara-C) is another agent which is commonly used for
intrathecal chemotherapy. The purpose of the study is to observe the effectiveness and safety
of concurrent RT and intrathecal chemotherapy for LM from solid tumors. In addition, the
effectiveness of these two types of agents (MTX and Ara-C) in the concurrent
chemo-radiotherapy will be compared in this study. This is a randomized controlled, parallel
group, and phase II clinical trial. The object of this study is newly diagnosis patients with
leptomeningeal metastases from solid tumors, who will accept the treatment of involved-field
RT combined with concurrent intrathecal-MTX or intrathecal-Ara-C, respectively. Major
endpoint is clinical response rate. Secondary endpoints are time to progression,severe
adverse events and overall survival.
Phase:
Phase 2
Details
Lead Sponsor:
First Hospital of Jilin University The First Hospital of Jilin University