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Intrathecal Pemetrexed with or without Radiotherapy for Leptomeningeal Metastasis
NCT05305885Phase 2
Key facts
- Status
- Unknown
- Start
- Aug 2022
- Primary completion
- Oct 2023
- Countries
- 1
- Sponsor
- The First Hospital of Jilin University
- Modality
- Small Molecules
- Drugs
- pemetrexed
- Conditions
- leptomeningeal metastasis (LM)
01
Overview
Phase 2, randomised, open-label trial of pemetrexed in leptomeningeal metastasis (LM) (2 arms), sponsored by The First Hospital of Jilin University. Primary endpoints: Clinical Response Rate up to 6 months and Incidence of Treatment-Related Adverse Events up to 6 months. Status: unknown.
02
Design
2 arms- Study design
- RandomizedOpen-label
IT Pemetrexed + Radiotherapy
Induction IT Pemetrexed followed by concurrent IT Pemetrexed and Involved-Field Radiotherapy
IT Pemetrexed Alone
Induction IT Pemetrexed followed by consolidation IT Pemetrexed
03
Who it enrols
Patients with confirmed leptomeningeal metastasis from solid tumors, no history of whole brain radiotherapy, and adequate organ function.
04
Endpoints
Primary
Clinical Response Rate
Incidence of Treatment-Related Adverse Events
Secondary
Overall Survival
Neurological Progression-Free Survival
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