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This study is a randomized phase III trial that aiming to investigate the role of dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) guided hypofractionated radiotherapy (hypo-RT) in patients with locally advanced non-small cell lung cancer (LA-NSCLC) who are planned to receive hypo-RT combined with concurrent chemotherapy and consolidative immunotherapy. Patients will be randomized in a 1:1 ratio into two groups:
The treatment-related toxicity, local control and long-term survival will be evaluated compared between MRI-guided and CT-guided hypo-RT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRI-based hypo-RT | Experimental | Patients will receive split-course hypo-RT combined with concurrent chemotherapy and consolidative immunotherapy. The experimental arm will undergo adaptive dose-painting hypo-RT based on DCE-MRI. |
|
| CT-based hypo-RT | Active Comparator | Patients will receive split-course hypo-RT combined with concurrent chemotherapy and consolidative immunotherapy. The control arm will undergo hypo-RT based on CT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DCE-MRI based split-course hypo-RT | Radiation | Tumor delineation will be based on DCE-MRI and CT. MRI help define the tumor boundary. Different radiation doses will be delivered based on the Ktrans value of the tumor area on DCE-MRI. |
| Measure | Description | Time Frame |
|---|---|---|
| treatment-related G2+ respiratory toxicity | the percentage of patients who developed G2+ respiratory toxicity, including pneumonitis and proximal bronchial tree toxicity | Recorded from the enrollment to 1 year after the completion of hypo-RT or 3 months after the completion of consolidative immunotherapy |
| progression-free survival rate | 2-year |
| Measure | Description | Time Frame |
|---|---|---|
| local control rate | 2-year | |
| overall survival rate | 2-year | |
| patient reported outcome assessed by QLQ-C30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bo Qiu, MD | Contact | 02087343031 | qiubo@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Hui Liu | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | China |
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| CT based split-course hypo-RT | Radiation | Tumor delineation will be based on CT. The total dose for both the first and boost courses of hypo-RT to the tumor area will be constant. |
|
| Concurrent chemotherapy | Drug | Concurrent Chemotherapy consists of weekly albumin-bound paclitaxel 50mg/m2, d1 plus cisplatin 25mg/m2,d1. |
|
| Consolidative immunotherapy | Drug | Consolidative PD-1/PD-L1 inhibitors |
|
assessed by QLQ-C30 |
| 2 year |
| patient reported outcome | assessed by QLQ-LC13 questionnaires | 2 year |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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