NCT06958614Completed
Prophylactic PEG-rhG-CSF During cCRT in LA-NSCLC
Efficacy and Safety of Primary Prophylactic Pegylated Recombinant Human Granulocyte Colony-Stimulating Factor During Definitive Concurrent Chemoradiotherapy for Inoperable Stage II-III Non-Small Cell Lung Cancer: A Prospective Cohort Study
Source: ClinicalTrials.gov · Last updated 6 May 2025
Brief summary (registry, in English)
Objective: To evaluate the efficacy and safety of prophylactic use of pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) during definitive concurrent chemoradiotherapy (cCRT) in patients with inoperable stage II-III non-small cell lung cancer (NSCLC). Methods: A prospective observational cohort study was conducted on patients receiving definitive cCRT. The radiation therapy technique uses intensity modulated radiation therapy (IMRT) and involves field irradiation. It protects more normal tissue from exposure.Chemotherapy regimens included platinum-based doublet combinations: etoposide plus cisplatin (every 28 days), pemetrexed plus platinum (every 21 days), or paclitaxel plus platinum (weekly, only for control group) . Patients were followed up at one month post-treatment, then every three months for the two year, and every six months thereafter until disease progression. In the study group, patients received subcutaneous injections of PEG-rhG-CSF (6 mg for patients weighing ≥45 kg, 3 mg for patients \<45 kg) 48 hours after each chemotherapy cycle during cCRT. In the control group, patients received guideline-based supportive treatment. Radiotherapy was halted or chemotherapy was delayed when grade 3 or more (G3+) toxicities happened. Endpoints:Primary endpoint was incidence of G3+ neutropenia during radiotherapy and one month post-radiotherapy. Complete blood counts were monitored weekly during cCRT and for one month post-treatment or as deemed necessary by the physician. Following the completion of cCRT and the resolution of acute side effects, patients were followed up at one month post-treatment, then every three months for the first year, and every six months thereafter until disease progression. Statistical Analysis:The inverse probability of treatment weighting (IPTW) algorithm was applied to balance differences between groups in terms of age, gender, smoking, clinical stage, KPS score, induction therapy received or not, ensuring the reliability of the study results. Statistical analysis was performed using R software (version 4.4.1). All tests were two-sided, with a P-value \<0.05 considered statistically significant.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 213 (actual)
- First submitted
- 28 Mar 2025
- Start date
- 2 Sept 2019
- Primary completion date
- 7 Nov 2024
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Diseases
- Lung cancer
- NCT number
- NCT06958614
What you commit to
- Study type: Observational
- Participants enrolled: 213
- From 2 Sept 2019 to the primary completion date, 7 Nov 2024
- 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, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active Malignancies
- Concurrent diagnosis of active malignancies (excluding: non-melanoma skin cancer, carcinoma in situ, or malignancies in complete remission for ≥5 years)
- Infectious/Immunological Conditions
- Active systemic infection requiring intravenous antimicrobial therapy
- Uncontrolled autoimmune diseases (defined as requiring systemic immunosuppressants at doses \>10 mg/day prednisone equivalent within 30 days prior to screening)
- Prior Radiotherapy
- History of thoracic radiotherapy involving \>30% lung parenchyma or mean heart dose \>20 Gy
Other illness
- Hypersensitivity Reactions
- Allergy to PEG-rhG-CSF or other biological products derived from genetically engineered Escherichia coli
- Neuropsychiatric Impairments
- Severe psychiatric disorders (e.g., schizophrenia, major depressive disorder with suicidal ideation) requiring hospitalization within 6 months)
Who the study is looking for
- Diagnosis
- Histologically confirmed stage II-III non-small cell lung cancer (NSCLC)
- Treatment Plan
- Planned to receive concurrent platinum-based chemotherapy with radiotherapy (cCRT)
- Demographics
- Age 18-80 years
- Performance Status
- Karnofsky Performance Status (KPS) ≥70
- Organ Function
- Renal function: Creatinine clearance ≥60 mL/min
- Hepatic function: Total bilirubin ≤1.5×ULN, AST/ALT ≤2.5×ULN
- Absolute neutrophil count ≥2.0×10⁹/L
- Platelets ≥100×10⁹/L
- Hemoglobin ≥10 g/dL
Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.