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The study evaluated the effectiveness, safety and immune effects of dose-painting radiation in patients with locally advanced non-small cell lung cancer.
The study evaluated the effectiveness, safety and immune effects of dose-painting radiation in patients with locally advanced non-small cell lung cancer.
The primary endpoint is PFS. Secondary points contains ORR, OS, HRQoL, and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Assigned Interventions | Experimental | Radiation therapy: Dose-painting radiation Systemic treatment: Choose a systemic treatment plan according to the patient's genetic testing status (1) Chemotherapy
(2) Targeted therapy: According to the patient's genetic testing status, molecular targeted therapy such as EGFR-TKI and ALK inhibitors can be selected; (3) Immunotherapy: According to the patient's genetic testing status, immunotherapy such as PD1/PD-L1 inhibitors can be selected; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dose-Painting Radiation | Radiation | Radiation therapy:
1) GTV-Tcentral: 2.0~2.5Gy/f, bid, 10-13d, physical dose 40-65Gy 2) GTV-Tperipheral: 3.0~4.0Gy/f, bid, 10-13d, physical dose 60-104Gy 3) GTV-N (mediastinal lymph node): 2.0Gy/f, bid, 10-13d, physical dose 40-52Gy |
| Measure | Description | Time Frame |
|---|---|---|
| FPS | progression-free survival (PFS) refers to the time from enrollment to the first recording of disease progression as determined by RECISTv1.1, or to death due to any cause (whichever occurs first). PFS will be analyzed in the ITT analysis set. | up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective response rate, according to RECISTv1.1, the proportion of patients with CR or PR was determined. If the patient has not undergone a post-baseline assessment, it is considered unremission | up to 3 years |
| OS |
| Measure | Description | Time Frame |
|---|---|---|
| Prognostic Biomarkers | The expression of lymphocyte subsets in peripheral blood, including CD3+ T cells, CD4+ T cells, CD8+ T cells, CD8+CD28+ T cells, CD8+CD28- T cells, Treg cells, NK cells, NKT cells, γδ T cells; | up to 8 weeks |
| Prognostic Biomarkers |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiahua Lyu, Doctor | Contact | +86-17713539529 | winlttljh@163.com | |
| Tao Li | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sichuan Cancer Hospital & Institute | Recruiting | Chengdu | Sichuan | 610041 | China |
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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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|
OS(Overall survival) refers to the time from enrollment to the first recorded death due to any cause (whichever occurs first).
| up to 3 years |
| HRQoL | HRQoL uses EORTCQLQ-C30 to assess the overall health of patients. The post-baseline score of the treatment group was studied, and the score changes from the baseline were summarized descriptively. | up to 3 years |
The changing trend of various cytokines in radiotherapy, including IL-6, IL-1b, IL-9, TNF-a, TGF-β, IL-10, IL-21, etc.
| up to 8 weeks |
| Yunnan Cancer Hospital | Recruiting | Kunming | China |
|
| Chongqing university three Gorges hospital | Recruiting | Wanzhou | China |
|
| General Hospital of Ningxia Medical University | Recruiting | Yingchuan | China |
|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |