Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05994339 |
Other study ID # |
20220808 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
Phase 2/Phase 3
|
First received |
|
Last updated |
|
Start date |
September 1, 2023 |
Est. completion date |
December 8, 2025 |
Study information
Verified date |
August 2023 |
Source |
Laibin People's Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Study Object: Stage III lung cancer with epidermal growth factor receptor (EGFR) sensitive
mutation.
Study Method: The study subjects will be randomly assigned to the intervention group and the
control group. The intervention group will receive radiotherapy combined with erlotinib
treatment, while the control group will receive concurrent radiotherapy combined with
chemotherapy. The differences in short-term efficacy, long-term efficacy, and incidence of
adverse reactions between the two groups will be observed.
Observation Indicators: Short-term efficacy indicators: Complete remission (CR) rate, partial
remission (PR) rate, and objective response rate (ORR). Long-term efficacy indicators:
Overall survival (OS) and progression-free survival (PFS). Adverse reaction indicators:
Incidence of lung toxicity, hematological toxicity, and gastrointestinal reactions.
Description:
The following tasks need to be completed at the time of enrollment: screening, signing the
informed consent form, random assignment according to the randomization table, detailed
patient medical history, physical examination, and collection of baseline chest-enhanced CT
as imaging data before treatment.
All eligible patients who meet the baseline inclusion criteria will be enrolled using an
online central randomization system, with the following stratification factors: disease
staging at the beginning of the study treatment (ⅢA vs ⅢB vs ⅢC), histology (adenocarcinoma
vs. others), and EGFR mutation status (exon 19 vs. exon 21). Patients will be randomly
assigned in a 1:1 ratio.
In the intervention group,Radiotherapy was administered using Intensity-Modulated Radiation
Therapy (IMRT) technique, with a prescribed dose of 60 Gy in 30 fractions. Ametinib was
orally administered at 110 mg per day, starting from the first day of radiotherapy and
continued for 42 days until the completion of radiotherapy, followed by continuous medication
until disease progression. In the control group,Radiotherapy was administered using
Intensity-Modulated Radiation Therapy (IMRT) technique, with a prescribed dose of 60 Gy in 30
fractions. Chemotherapy with paclitaxel at 135 mg/m2 and cisplatin at 70 mg/m2 was
intravenously infused for two cycles during the 1st and 4th weeks. After the completion of
radiotherapy, there was a rest period of 4 weeks, followed by continuation of the TP regimen
for consolidation chemotherapy for 4 cycles.
Follow-up will take place from August 30, 2023, to December 30, 2025, based on the time of
death. Chest and upper abdominal enhanced CT, cervical supraclavicular lymph node color
Doppler ultrasound, head MRI, whole-body bone scan, and other examinations will be performed
at treatment completion, 1 month after treatment completion, 3 months after treatment
completion, every 3 months within 2 years, and every 6 months in the 3rd year for efficacy
and survival evaluation.
Statistical Analysis:
① Stratified (based on disease stage at the beginning of the study treatment, histology, and
EGFR mutation status) and unstratified log-rank tests will be used to compare
Progression-Free Survival (PFS) and Overall Survival (OS) at a two-sided significance level
of 0.05. The median PFS and corresponding 95% confidence intervals (CI) for both groups will
be calculated.
② Cox proportional hazards models will be used to estimate Hazard Ratios (HRs) and 95% CI for
PFS and OS. PFS and OS curves will be estimated using the Kaplan-Meier method.
③ Fisher's exact test will be used to compare the difference in Objective Response Rate (ORR)
between the two groups. The difference in ORR and its 95% CI will be presented together using
the normal approximation method.