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To investigate the efficacy of carbon ion therapy for stage Ia-IIa primary peripheral non-small cell lung cancer (NSCLC). The primary endpoint was progression-free survival (PFS), and the secondary endpoint was local control rate, overall survival (OS) and toxicities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study arm | Experimental | patients received carbon ion radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbon ion beam radiotherapy | Radiation | Patients receive carbon ion radiotherapy of 12GyE per fraction, totally 4 fractions. Patients with tumors ≥4cm should receive at least 4 cycles of platinum-based doublet chemotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| disease progression-free survival rate | disease progression-free survival rate was defined from the start of carbon ion radiotherapy till the date of disease progression at any site or death, or the last follow up. | From date of radiotherapy started until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
| Measure | Description | Time Frame |
|---|---|---|
| local control rate | local control rate was defined was defined from the start of carbon ion radiotherapy till the date of local failure or the last follow-up | From date of radiotherapy started until the date of first documented local disease progression, assessed up to 100 months |
| overall survival rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Li | Contact | 86-21-38296678 | jing.li@sphic.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jingfang Mao, PHD | Shanghai Proton and Heavy Ion Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Proton and Heavy Ion Center | Recruiting | Shanghai | Shanghai Municipality | 201513 | 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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overall survival rate was defined from the start of carbon ion radiotherapy till the date of death or the last follow-up |
| From date of radiotherapy started until the date of death from any cause, assessed up to 100 months |
| Incidence of Treatment-induced Adverse Events [Safety and Tolerability] | Treatment-induced toxicities were scored using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, for events observed after the first dose of irradiation. Toxicities occurred 90 or more days after the completion of CIRT were defined as late toxicities. | From date of radiotherapy started, every 3-4 months within the first 2 years, every 6 months between years 3 and 5, and annually thereafter, assessed up to 100 months |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |