An observational study in Stage II-III Non-small Cell Lung Cancer, Concurrent Chemotherapy and Conditions Influencing Health Status, sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-06.
Sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Observational
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.
6,641 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.
This study's enrollment of 213 is above the median of 164 across 974 observational studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Cancer Institute and Hospital, Chinese Academy of Medical Sciences is the lead sponsor of 387 studies on the registry; 275 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Definitive Concurrent Chemoradiotherapy for Inoperable Stage II-III Non-Small Cell Lung Cancer，Patients received prophylactic PEG-rhG-CSF 48 hours after chemotherapy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosis
Treatment Plan
Demographics
Performance Status
Organ Function
Exclusion Criteria:
Active Malignancies
Infectious/Immunological Conditions
Hypersensitivity Reactions
Neuropsychiatric Impairments
Prior Radiotherapy
The experimental group received prophylactic PEG-rhG-CSF 48 hours after chemotherapy
Grade 3 or more (G3+) neutropenia
According to the Radiation Therapy Oncology Group (RTOG) acute radiation injury grading scale
Time frame: From the first day of radiotherapy to one month after the end of radiotherapy
treatment delays
Chemotherapy delay
Time frame: Chemotherapy delay was defined as a delay of ≥7 days
interruptions
Radiotherapy interruption
Time frame: Break in radiotherapy of ≥3 days
G3+ thrombocytopenia and anemia
According to the Radiation Therapy Oncology Group (RTOG) acute radiation injury grading scale
Time frame: From the first day of radiotherapy to one month after the end of radiotherapy
G2+ acute radiation esophagitis (RE) and pneumonitis (RP)
According to the Radiation Therapy Oncology Group (RTOG) acute radiation injury grading scale
Time frame: From the first day of radiotherapy to six month after the end of radiotherapy
progression-free survival (PFS)
the time from the start of cCRT to the first event of disease progression
Time frame: assessed up to 72 months
overall survival (OS)
the time from the start of cCRT to death from any cause
Time frame: assessed up to 72 months
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Carcinoma, Non-Small-Cell Lung →
Cancer Institute and Hospital, Chinese Academy of Medical Sciences →