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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
Sponsor: The Second Hospital of Anhui Medical University
Summary
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.
Official title: Primary Prophylaxis With PEG-rhG-CSF Versus Therapeutic Short-Acting rhG-CSF for Neutropenia During and After Pelvic Chemoradiotherapy in Patients With Cervical or Endometrial Cancer: A Randomized Controlled Trial
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2026-09-15
Completion Date
2028-12-31
Last Updated
2026-10-08
Healthy Volunteers
No
Conditions
Interventions
Pegylated Recombinant Human Granulocyte Colony-Stimulating Factor (PEG-rhG-CSF)
PEG-rhG-CSF was administered as primary prophylaxis during pelvic radiotherapy. Participants receiving chemotherapy received PEG-rhG-CSF subcutaneously 24 hours after each chemotherapy cycle. Participants with body weight ≥45 kg received 6 mg, and those with body weight \<45 kg received 3 mg. Participants receiving radiotherapy alone received a single dose 24-48 hours before the first radiotherapy fraction.
Recombinant Human Granulocyte Colony-Stimulating Factor (rhG-CSF)
Short-acting rhG-CSF was not administered prophylactically. Treatment was initiated when ANC decreased to \<1.0 × 10\^9/L. rhG-CSF was administered subcutaneously at 150-300 μg/day until ANC reached ≥5.0 × 10\^9/L or white blood cell count reached ≥10.0 × 10\^9/L.
Locations (1)
The Second Hospital of Anhui Medical University
Hefei, Anhui, China