NCT07865650Active, not recruiting
PEG-rhG-CSF Primary Prophylaxis vs Therapeutic Short-Acting rhG-CSF for Neutropenia During Pelvic Chemoradiotherapy in Cervical or Endometrial Cancer
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
Source: ClinicalTrials.gov · Last updated 8 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 14 Sept 2026
- Start date
- 15 Sept 2026
- Primary completion date
- 30 Sept 2028
- Lead sponsor
- The Second Hospital of Anhui Medical University
- Diseases
- Endometrial cancer, Cervical cancer
- NCT number
- NCT07865650
What you commit to
- Study type: Interventional
- Planned participants: 90
- From 15 Sept 2026 to the primary completion date, 30 Sept 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent other primary malignancy.
Other illness
- Hematologic disease or known bone marrow dysfunction.
Lab values
- Pre-existing grade ≥2 neutropenia before radiotherapy, defined as ANC \<1.5 × 10⁹/L.
- Insufficient baseline clinical or laboratory information to determine study eligibility.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Second Hospital of Anhui Medical University Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.