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PEG-rhG-CSF Primary Prophylaxis vs Therapeutic Short-Acting rhG-CSF for Neutropenia During Pelvic Chemoradiotherapy in Cervical or Endometrial Cancer

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
This single-center, prospective, randomized, open-label controlled study evaluates primary prophylaxis with pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) compared with a therapeutic short-acting recombinant human granulocyte colony-stimulating factor (rhG-CSF) strategy in patients with cervical or endometrial cancer receiving pelvic radiotherapy with or without chemotherapy. Participants will be randomly assigned in a 1:1 ratio to the PEG-rhG-CSF primary prophylaxis group or the short-acting rhG-CSF treatment group. The primary objective is to compare the incidence of grade 3 or higher neutropenia during radiotherapy. Secondary objectives include febrile neutropenia, treatment delay or interruption, chemotherapy dose reduction, treatment-related adverse events, post-radiotherapy hematologic toxicity and recovery, and exploratory progression-free survival.
Trial Details
NCT Number NCT07865650
Lead Sponsor The Second Hospital of Anhui Medical University
Conditions
(from sponsor)		 Cervical Cancer, Endometrial Cancer
Related terms Endometrial Neoplasms, Uterine Cervical Neoplasms
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov