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| ID | Type | Description | Link |
|---|---|---|---|
| ZLRK202524 | Other Grant/Funding Number | Beijing Hospitals Authority |
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| Name | Class |
|---|---|
| Tianjin Chest Hospital | OTHER |
| Peking University First Hospital | OTHER |
| Bethune First Hospital of Jilin University | UNKNOWN |
| Beijing Friendship Hospital |
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It is a prospective, multicenter, randomized controlled trial to investigate the predictive value of MRD on adjuvant therapy. Stage IA2-II resected NSCLC patients will undergo two-round MRD tests after surgery, first in 3-7 days and second in 1 month after surgery. And patients who confirm two-round landmark undetectable MRD will be enrolled and randomly assigned to the conventional treatment group or the adaptive therapy group . Patients in the the adaptive therapy group will undergo closely MRD and imaging monitoring without adjuvant therapy if the MRD was negative.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Therapy | Active Comparator | Patients in this group will be treated following the guidelines. |
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| Adaptive Therapy | Experimental | Patients in this group will undergo closely MRD and imaging monitoring without adjuvant therapy if the MRD was negative. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Therapy | Drug | For patients with negative EGFR/ALK mutation, adjuvant chemotherapy or adjuvant chemotherapy combined with immunotherapy was administered, for patients with positive EGFR/ALK mutation, targeted therapy was administered. |
| Measure | Description | Time Frame |
|---|---|---|
| Two-years disease free survival rates | The 2-year DFS rate of patients in both arms | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Use of adjuvant therapy | Differences in adjuvant therapy use between the Adaptive Therapy group (no adjuvant therapy if MRD persistently negative and initiation of adjuvant therapy if MRD positive) and the Standard Treatment Group | 2 years |
| Questionnaire on Quality of Life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luyan Shen, Ph.D. | Contact | 86-1581140843 | shenluyan@pku.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Shaohua Ma, M.D. | Peking University Cancer Hospital & Institute, Beijing 100142, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Cancer Hospital & Institute | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| OTHER |
| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
| Liaoning Cancer Hospital & Institute | OTHER |
| Geneplus-Beijing Co. Ltd. | INDUSTRY |
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| Adaptive Therapy | Other | Patients will be under close MRD and imaging monitoring without adjuvant therapy if the MRD was negative. |
|
Differences in the Quality of Life between the Adaptive Therapy group (no adjuvant therapy if MRD persistently negative and initiation of adjuvant therapy if MRD positive) and the Standard Treatment Group, by using Generalized Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire-9 (PHQ-9), and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30, V3) |
| 2 years |
| Five-years disease free survival rates | The 5-year DFS rate of patients in both arms | 5 years |