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Prophylactic PEG-rhG-CSF During cCRT in LA-NSCLC

NCT06958614 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 213

Last updated 2025-05-06

No results posted yet for this study

Summary

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.

Conditions

  • Stage II-III Non-small Cell Lung Cancer
  • Concurrent Chemotherapy
  • Conditions Influencing Health Status

Interventions

DRUG

Primary Prophylactic Pegylated Recombinant Human Granulocyte Colony-Stimulating Factor

The experimental group received prophylactic PEG-rhG-CSF 48 hours after chemotherapy

Sponsors & Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-02
Primary Completion
2024-11-07
Completion
2025-01-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06958614 on ClinicalTrials.gov