Cervical CancerNCT07865650
PEG-rhG-CSF Primary Prophylaxis vs Therapeutic Short-Acting rhG-CSF for Neutropenia During Pelvic Chemoradiotherapy in Cervical or Endometrial Cancer
A study testing Pegylated Recombinant Human Granulocyte Colony-Stimulating Factor (PEG-rhG-CSF) and Recombinant Human Granulocyte Colony-Stimulating Factor (rhG-CSF) in people with Cervical Cancer and Endometrial Cancer, run by The Second Hospital of Anhui Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer, Endometrial Cancer
- What is being tested?
- Pegylated Recombinant Human Granulocyte Colony-Stimulating Factor (PEG-rhG-CSF) and Recombinant Human Granulocyte Colony-Stimulating Factor (rhG-CSF)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed cervical cancer, including squamous cell carcinoma or adenocarcinoma, or endometrial cancer.
- Planned to receive pelvic external-beam radiotherapy, with or without three-dimensional intracavitary brachytherapy.
- Eligible for and willing to undergo random assignment to one of the two G-CSF treatment strategies.
- Written informed consent provided before enrollment.
Who cannot join
- Concurrent other primary malignancy.
- Pre-existing grade ≥2 neutropenia before radiotherapy, defined as ANC <1.5 × 10⁹/L.
- Hematologic disease or known bone marrow dysfunction.
- Insufficient baseline clinical or laboratory information to determine study eligibility.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230601
About this study
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
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.
Read the detailed description
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.
- Conditions
- Cervical Cancer, Endometrial Cancer
- Being tested
- Pegylated Recombinant Human Granulocyte Colony-Stimulating Factor (PEG-rhG-CSF), Recombinant Human Granulocyte Colony-Stimulating Factor (rhG-CSF)
- Medical subject headings
- Uterine Cervical Neoplasms, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated Recombinant Human Granulocyte Colony-Stimulating Factor (PEG-rhG-CSF)Drug
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)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| PEG-rhG-CSF Primary Prophylaxis | Experimental | 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. Receives: Drug: Pegylated Recombinant Human Granulocyte Colony-Stimulating Factor (PEG-rhG-CSF) |
| Short-Acting rhG-CSF Treatment | Active comparator | 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. Receives: Drug: Recombinant Human Granulocyte Colony-Stimulating Factor (rhG-CSF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Grade 3 or Higher Neutropenia During Radiotherapy
Measured: 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
Measured: From completion of RT through 6 months after the final RT fraction or final chemotherapy cycle, as applicable
Secondary outcomes (5)
Incidence of Febrile Neutropenia
Measured: Baseline, weekly during concurrent chemoradiotherapy (up to 6 weeks), and at 1, 3, and 6 months after radiotherapy.
Radiotherapy Delay or Interruption
Measured: Weekly during the planned radiotherapy course (up to 6 weeks).
Incidence of Chemotherapy Delay or Interruption Assessed by Chemotherapy Cycle Duration
Measured: At the end of each chemotherapy cycle (each cycle is 21 days), up to 3 cycles
Chemotherapy Dose Change
Measured: Baseline, and at the end of each chemotherapy cycle (each cycle is 21 days), up to 3 cycles
Treatment-Related Adverse Events
Measured: From initiation of study treatment through 6 months after completion of RT or chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start15 Sep 2026
- Primary completion30 Sep 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan yan, Hong, The Second Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07865650
- Sponsor's protocol ID
- YX2024-014(F1)
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07865650
- Acronym / sponsor ID
- YX2024-014(F1)
- Conditions
- Cervical Cancer, Endometrial Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The Second Hospital of Anhui Medical UniversityUniversity, hospital or other
- Study start
- 15 Sep 2026 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 8 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG-rhG-CSF Primary Prophylaxis | Experimental | Drug: Pegylated Recombinant Human Granulocyte Colony-Stimulating Factor (PEG-rhG-CSF)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. |
| Short-Acting rhG-CSF Treatment | Active comparator | Drug: Recombinant Human Granulocyte Colony-Stimulating Factor (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically confirmed cervical cancer, including squamous cell carcinoma or adenocarcinoma, or endometrial cancer.
- Planned to receive pelvic external-beam radiotherapy, with or without three-dimensional intracavitary brachytherapy.
- Eligible for and willing to undergo random assignment to one of the two G-CSF treatment strategies.
- Written informed consent provided before enrollment.
Key exclusion criteria (4 listed)
- Concurrent other primary malignancy.
- Pre-existing grade ≥2 neutropenia before radiotherapy, defined as ANC <1.5 × 10⁹/L.
- Hematologic disease or known bone marrow dysfunction.
- Insufficient baseline clinical or laboratory information to determine study eligibility.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | PEG-rhG-CSF Primary Prophylaxis |
| 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. | Drug | Short-Acting rhG-CSF Treatment |
Primary outcome
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
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: Yes
Related trials for Cervical Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pegylated Recombinant Human Granulocyte Colony-Stimulating Factor (PEG-rhG-CSF) and Recombinant Human Granulocyte Colony-Stimulating Factor (rhG-CSF) in people with Cervical Cancer and Endometrial Cancer, run by The Second Hospital of Anhui Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.