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This study is an open-label, single-arm phase 2 trial to evaluate the efficacy and safety of stereotactic radiotherapy (SRT) for patients with oligo-residual NSCLC after 3rd generation EGFR-TKIs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3rd generation EGFR-TKI+ SRT | Experimental | Patients were treated with the intent to ablate all residual disease with consolidative SRT. EGFR-TKI treatment was continued during and after consolidative SRT until disease progression or intolerable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3rd generation EGFR-TKI | Drug | Osimertinib will be administered orally at the dose of 80 mg once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | PFS was measured from the date of enrollment to the date of disease progression as defined by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 or death due to any cause, whichever occurred first. For patients whose disease did not progress, PFS was evaluated by censoring patients at their most recent imaging. | Two years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events | Treatment-related adverse events were assessed and graded according to CTCAE v. 5.0. | Two years |
| Overall Survival | OS was defined as the time from the date of enrollment until death by any cause. Participants still alive at the time of data analysis were censored at the date of last follow-up. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhengfei Zhu, MD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39398493 | Derived | Zhou Y, Peng L, Liang F, Chu L, Chu X, Yang X, Zhang J, Guo T, Jiang S, Pang Y, Wang Z, Zhang L, Ni J, Zhu Z. Safety and efficacy of consolidative stereotactic radiotherapy for oligo-residual EGFR-mutant non-small cell lung cancer after first-line third-generation EGFR-tyrosine kinase inhibitors: a single-arm, phase 2 trial. EClinicalMedicine. 2024 Sep 26;76:102853. doi: 10.1016/j.eclinm.2024.102853. eCollection 2024 Oct. |
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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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| ID | Term |
|---|---|
| C000596361 | osimertinib |
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| Consolidative SRT | Radiation | Patients who possess oligoresidual disease after 3rd generation EGFR-TKI therapy will be treated with the intent to ablate all residual disease with consolidative SRT. The choice of dose-fractionation regimen is at the discretion of the treating radiation oncologist. TKI will be continued during and after consolidative SRT until disease progression or intolerable toxicity. |
|
| Two years |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |