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The treatment modality with immunotherapy has been the first-line standard treatment for advanced NSCLC. But more than 2/3 patients still develop acquired drug resistance within 5 years of immunotherapy, and more than 1/2 patients are oligoprogressive. Stereotactic body radiation therapy (SBRT) plays a growing role in the management of oligometastatic disease. This study aims to evaluate the efficacy and safety of SBRT for oligoprogressive NSCLC after first line treatment with immune checkpoint inhibitors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SBRT | Experimental | Patients with oligoprogressive NSCLC after first line treatment with immune checkpoint inhibitors will be treated with SBRT for all progressing lesions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBRT | Radiation | Patients with oligoprogressive NSCLC after first line treatment with immune checkpoint inhibitors will be treated with SBRT for all progressing lesions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progress free survival | PFS was defined from the date of enrollment to the date of disease progression | two years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | OS was defined from the date of enrollment until death by any cause or last follow-up. | two years |
| Grade 3 or higher toxicity | Treatment-related grade 3 or higher adverse events according to CTCAE 5.0. |
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Inclusion Criteria:
Adequate bone marrow function: white blood cell (WBC) count ≥ 3.0 * 10 ^ 9/L or neutrophil count ≥ 1.5 * 10 ^ 9/L, platelet count ≥ 100 * 10 ^ 9/L and hemoglobin ≥90g/L,; Adequate hepatic function: total bilirubin, urea nitrogen and serum creatinine≤ 1.5 x upper limit of normal (ULN). Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤2.0 ULN;
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaojing Lai | Contact | 13819480002 | laixj@zjcc.org.cn | |
| Min Fang, MD | Contact | 13738152645 | fangmin@zjcc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xiaojing Lai | Department of Thoracic Radiotherapy, Zhejiang Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310022 | 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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| two years |
| Time to new metastasis | Time to new metastasis was defined from the date of enrollment to the date of new lesion progression. | 2 years |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |