An interventional study of Pegylated Recombinant Human Granulocyte Colony-Stimulating Factor (PEG-rhG-CSF) and Recombinant Human Granulocyte Colony-Stimulating Factor (rhG-CSF) in Cervical Cancer and Endometrial Cancer, sponsored by The Second Hospital of Anhui Medical University. Active, not recruiting at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by The Second Hospital of Anhui Medical University · Not applicable, Interventional, and Supportive care
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.
Patients with histologically confirmed cervical cancer or endometrial cancer who are scheduled to receive pelvic external-beam radiotherapy, with or without chemotherapy, are being enrolled in this single-center randomized controlled study. Participants are randomly assigned in a 1:1 ratio to two treatment strategies.
Participants assigned to the PEG-rhG-CSF primary prophylaxis group receive prophylactic PEG-rhG-CSF without waiting for a decrease in absolute neutrophil count (ANC). For participants receiving a 3-week chemotherapy regimen, PEG-rhG-CSF is administered subcutaneously 24 hours after completion of each chemotherapy cycle at a dose of 6 mg for body weight ≥45 kg or 3 mg for body weight \<45 kg. Participants receiving radiotherapy alone receive a single subcutaneous dose 24-48 hours before the first radiotherapy fraction using the same weight-based dosing scheme.
Participants assigned to the short-acting rhG-CSF treatment group do not receive prophylactic G-CSF. Short-acting rhG-CSF is initiated when ANC decreases to \<1.0 × 10⁹/L, at a dose of 150-300 μg/day subcutaneously, and is continued until ANC reaches ≥5.0 × 10⁹/L or white blood cell count reaches ≥10.0 × 10⁹/L.
The primary endpoint is the incidence of grade ≥3 neutropenia during radiotherapy according to CTCAE version 5.0. Secondary outcomes include febrile neutropenia, treatment delay or interruption, chemotherapy dose reduction, treatment-related adverse events, hematologic toxicity during the post-radiotherapy observation period, and exploratory progression-free survival. Post-treatment hematologic outcomes are followed for up to 6 months after the final radiotherapy fraction or final chemotherapy cycle, whichever occurs later.
1,927 studies on the registry are indexed under Uterine Cervical Neoplasms; 576 are open to participants now.
This study's planned enrollment of 90 is close to the median of 100 across 1,411 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →The Second Hospital of Anhui Medical University is the lead sponsor of 30 studies on the registry; 18 are open to participants now.
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Exclusion Criteria:
Participants receive primary prophylaxis with PEG-rhG-CSF during pelvic radiotherapy. For participants receiving 3-week chemotherapy, PEG-rhG-CSF is administered subcutaneously 24 hours after each chemotherapy cycle at 6 mg for body weight ≥45 kg or 3 mg for body weight \<45 kg. Participants receiving radiotherapy alone receive a single dose 24-48 hours before the first radiotherapy fraction.
Drug: Pegylated Recombinant Human Granulocyte Colony-Stimulating Factor (PEG-rhG-CSF)
Participants do not receive prophylactic G-CSF. Short-acting rhG-CSF is initiated when ANC is \<1.0 × 10⁹/L and is administered subcutaneously at 150-300 μg/day until ANC reaches ≥5.0 × 10⁹/L or WBC reaches ≥10.0 × 10⁹/L.
Drug: Recombinant Human Granulocyte Colony-Stimulating Factor (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.
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.
Incidence of Grade 3 or Higher Neutropenia During Radiotherapy
Time frame: From the first day of pelvic radiotherapy through completion of radiotherapy, approximately 5-7 weeks
Incidence of Grade 3 or Higher Neutropenia During the Post-Radiotherapy Observation Period
Time frame: From completion of RT through 6 months after the final RT fraction or final chemotherapy cycle, as applicable
Incidence of Febrile Neutropenia
Time frame: Baseline, weekly during concurrent chemoradiotherapy (up to 6 weeks), and at 1, 3, and 6 months after radiotherapy.
Radiotherapy Delay or Interruption
Time frame: Weekly during the planned radiotherapy course (up to 6 weeks).
Incidence of Chemotherapy Delay or Interruption Assessed by Chemotherapy Cycle Duration
Time frame: At the end of each chemotherapy cycle (each cycle is 21 days), up to 3 cycles
Chemotherapy Dose Change
Time frame: Baseline, and at the end of each chemotherapy cycle (each cycle is 21 days), up to 3 cycles
Treatment-Related Adverse Events
Time frame: From initiation of study treatment through 6 months after completion of RT or chemotherapy
Exploratory Progression-Free Survival
Time frame: From initiation of study treatment until disease progression, recurrence/metastasis, death from any cause, or last follow-up; assessed up to approximately 30 months
Plan to share: Yes
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Studies of the drug tested here: Filgrastim
The Second Hospital of Anhui Medical University