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Shenjie for Prevention of Oxaliplatin-Induced Neurotoxicity in Gastric Cancer
NCT02024438Phase 3
Key facts
- Status
- Unknown
- Start
- Dec 2013
- Primary completion
- Dec 2016
- Countries
- 1
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Modality
- Recombinant Proteins and Enzymes
- Conditions
- chemotherapy-induced peripheral neuropathy (CIPN)
01
Overview
Phase 3, randomised, double-blind trial in chemotherapy-induced peripheral neuropathy (CIPN) comparing Shenjie + mFOLFOX6 with Placebo + mFOLFOX6 (2 arms). Primary endpoint: The incidence of neurotoxicity including acute neurotoxicity and accumulating neurotoxicity up to 12 months. Status: unknown.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Shenjie + mFOLFOX6
Monosialotetrahexosylganglioside Sodium (40mg) + mFOLFOX6 every 2 weeks
Placebo + mFOLFOX6
Saline placebo + mFOLFOX6 every 2 weeks
03
Who it enrols
Patients with metastatic gastric cancer (note: inclusion criteria text mentions colorectal cancer, likely a typo given the title) who have not received first-line chemotherapy, with Karnofsky scores 60-80, and no pre-existing severe neurotoxicity.
04
Endpoints
Primary
The incidence of neurotoxicity including acute neurotoxicity and accumulating neurotoxicity
Secondary
Objective response rate
Progress Free Survival
overall Survival
quality of life
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