drugset / Trial / NCT04542356

Study on the Efficacy and Safety of PEG-rhG-CSF in Preventing Neutropenia During Concurrent Chemoradiotherapy of Cervical Cancer

NCT04542356

Phase 2 Completed 60 enrolled Chongqing University Cancer Hospital
RandomizedParallel-groupOpen-labelPrevention

Summary

This randomized controlled prospective study aims to explore the efficacy and safety of using (PEGylated Recombinant Human Granulocyte Stimulating Factor) PEG-rhG-CSF to prevent neutropenia during concurrent chemoradiotherapy of paclitaxel and cisplatin (TP) regimen for cervical cancer. To find out the best time to use PEG-rhG CSF, and to explore investigate the effect of PEG-rhG-CSF on long-term bone marrow function in the process of concurrent chemoradiotherapy, and finally to explore the clinical feasibility of using PEG-rhG-CSF to prevent neutropenia during concurrent chemoradiotherapy of TP regimen for cervical cancer.

Timeline

Start
2018-08-01
Primary completion
2021-01-26
Completion
2021-05-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Pegfilgrastim Protein / enzyme biologic 6 mg Subcutaneous
Background filgrastim Protein / enzyme biologic 5 ug/kg

Indications