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| ID | Type | Description | Link |
|---|---|---|---|
| No. 2024-SR-1028 | Other Identifier | Jiangsu Province Hospital |
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Brief Summary The goal of this clinical trial is to evaluate the effect of postoperative adjuvant chemotherapy (ACT) in patients with stage I non-squamous non-small cell lung cancer (NSCLC) after curative resection.
The main questions it aims to answer are:
Does ACT improve recurrence-free survival (RFS) compared with observation alone?
Does ACT provide disease-free survival (DFS) benefit in this patient population?
Researchers will compare the adjuvant chemotherapy group with the observation group to see if chemotherapy reduces the risk of recurrence and improves survival outcomes.
Participants will:
Receive standard platinum-based adjuvant chemotherapy after surgery or undergo regular postoperative surveillance according to institutional guidelines.
Be followed at scheduled intervals with clinical assessments and imaging to monitor for recurrence and survival outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adjuvant chemotherapy |
| ||
| Postoperative Observation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adjuvant chemotheapy | Drug | apply adjuvant chemotheapy |
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| Measure | Description | Time Frame |
|---|---|---|
| 5-year Disease-Free Survival (DFS), defined as time from surgery to recurrence or death, estimated by Kaplan-Meier method. | DFS is defined as the time from surgery to the first documented recurrence or death from any cause, whichever occurs first. Patients without an event will be censored at the last follow-up. Data will be summarized using Kaplan-Meier survival analysis, with median DFS and 95% confidence intervals. | Up to 5 years after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 5-year Recurrence-Free Survival (RFS), defined as time from surgery to the first recurrence or death from any cause, estimated by Kaplan-Meier method | RFS is defined as the time from surgery to the date of first documented tumor recurrence (local, regional, or distant) or death from any cause, whichever occurs first. Patients who are alive and recurrence-free will be censored at the date of last follow-up. Data will be analyzed using Kaplan-Meier survival estimates, with median RFS and 95% confidence intervals reported. |
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Inclusion Criteria:
Exclusion Criteria:
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patients with non-squamous NSCLC from four participating hospitals
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| Up to 5 years after surgery. |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |