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Randomized phase II trial aims to compare surgery with or without adjuvant chemotherapy in treating patients who are pathologically diagnosed as stage I lung adenocarcinoma with micropapillary component no less than 20%.
The presence of micropapillary component in adenocarcinoma is a predictor of poor prognosis, and has been reported to be to be chemosensitive to platinum-based chemotherapy. Seeking a more appropriate treatment for these patients, we perform this randomized phase II clinical trial. About 460 stage I lung adenocarcinoma patients with micropapillary component ≥ 20% will be included and divided into two group. Patients in the control group will only undergo complete R0 resection of the lesion, no further therapy will be used. While patients in the experimental group are going to receive platinum-based chemotherapy (comprising cisplatin and pemetrexed disodium)about 1 month after therapeutic surgery. Treatment continues every 3 weeks for 4 courses. Clinic and telephone follow up will be conducted for survival data monitoring.
DFS(disease free survival rate) and OS(overall survival rate) curves will be calculated using the Kaplan-Meier, life-table method. Comparison of the survival curve for the two groups will be performed using the log-rank test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Active Comparator | Undergo surgery, followed by observation. Patients receive no further therapy |
|
| Arm II | Experimental | Undergo surgery, followed by chemotherapy (cis Platinum/Carboplatin, Pemetrexed Disodium). Patients receive chemotherapy comprising cisplatin 75mg/m2 or Carboplatin AUC=5mg/ml/min, and pemetrexed 500mg/m2 in day 1. Treatment continues every 3 weeks for 4 courses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cis Platinum/Carboplatin, Pemetrexed Disodium | Drug | Intravenous inject Pemetrexed Disodium for Injection over 10 minutes, waiting for at least 30 minutes, then followed by cis Platinum/ Carboplatin over 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-Free-Survival-Rate | the percentage of people in the trial who are alive and cancer free after a specified number of years | up to 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall-Survival-Rate | the percentage of people in the trial who alive, with or without signs of cancer | up to 60 months |
| Disease-Free-Survival-Time | From date of diagnosis until the date of first documented progression or date of cancer related death , whichever came first |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yingran Shen, PhD | Contact | 86-18117166317 | elaineshen91@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thoracic Surgery Department of Shanghai Pulmonary Hospital | Recruiting | Shanghai | 200000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42266006 | Derived | Zhou Y, Bian D, Yang F, Xu X, Shen Y, Chen L, Dai J, Xu X, Zhu Y, Zhao D, Zhang P, Liu X, Jin K, Jiang G. Adjuvant chemotherapy for resected stage-ia lung adenocarcinoma with micropapillary histologic pattern. Interdiscip Cardiovasc Thorac Surg. 2026 Jun 9:ivag165. doi: 10.1093/icvts/ivag165. Online ahead of print. |
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|
| Undergo surgery | Procedure | Therapeutic conventional surgery, R0 resection |
|
| up to 60 months |
| Overall-Survival-Time | Time from randomization until death from any cause | up to 60 months |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 18, 2023 | Feb 13, 2023 | 3 |
| ID | Term |
|---|---|
| D000077192 | Adenocarcinoma of Lung |
| D009370 | Neoplasms by Histologic Type |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009369 | Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| D000068437 | Pemetrexed |
| D007267 | Injections |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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