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This study included patients with early-stage lung cancer cT1-3N0M0, stage IA-IIB (American Joint Committee on Cancer eighth edition staging, AJCC 8th ) who were inoperable or refused surgery. They were divided into peripheral type and central type according to the tumor location and received radical Stereotactic Body Proton Therapy (SBPT) for Early-Stage Non-Small Cell Lung Cancer. The prescribed dose for patients with peripheral lung cancer is 48-60Gray(Gy) (Relative Biological Effectiveness, RBE)/4-6 fractions, and for patients with central lung cancer, the prescribed dose is 50-70Gy(RBE)/10-15 fractions. After treatment, follow-up visits will be conducted to observe short-term and long-term efficacy, adverse reactions and patient quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic Body Proton Therapy | Experimental | The prescribed dose for patients with peripheral lung cancer is 48-60Gy(RBE)/4-6 fractions, and for patients with central lung cancer, the prescribed dose is 50-70Gy(RBE)/10-15 fractions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Body Proton Therapy | Radiation | They were divided into peripheral type and central type according to the tumor location and received radical SBPT for Early-Stage Non-Small Cell Lung Cancer. . The prescribed dose for patients with peripheral lung cancer is 48-60Gy(RBE)/4-6 fractions, and for patients with central lung cancer, the prescribed dose is 50-70Gy(RBE)/10-15 fractions. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Progression Free Survival(PFS) is defined as time from initiation of SBPT to disease progression or death from any cause. Estimated by the Kaplan-Meier method | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall Survival (OS) is defined as time from initiation of SBPT to patient death from any cause. Estimated by the Kaplan-Meier method. | UP to 3 years |
| Local Control Rate | Local control rate is defined as the proportion of participants with the absence of local failure among patients evaluable for efficacy in three years. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Taize Yuan Professor, Doctor | Contact | 8620-32506160 | taize.yuan@ccm.cn |
| Name | Affiliation | Role |
|---|---|---|
| Taize Yuan, Doctor | Guangzhou Concord Cancer Center,Guangzhou, Guangdong | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou Concord Cancer Center | Recruiting | Guangzhou | Guangdong | China |
Yes. I plan to share relevant non-confidential research progress and academic achievements of this IPD with peer researchers through academic exchanges and academic conferences, while strictly keeping core confidential data undisclosed to comply with clinical research confidentiality rules.
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Up to 3 years |
| Quality of life scores | European Organisation for Research and Treatment of Cancer quality of life questionnaire-core 30 (EORTC QLQ-C30) (V3.0) scores before treatment, weekly during treatment, at the end of treatment, and at each follow-up visit | Up to 3 years |
| Quality of life scores | European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer Module 29(EORTC QLQ-LC29) scores before treatment, weekly during treatment, at the end of treatment, and at each follow-up visit | Up to 3 years |
| Rate of grade 3-5 adverse events | The proportion of subjects with toxic reactions of levels 3, 4 and 5 during the clinical trial period.The researchers record adverse events(AE) that appeared during the clinical trial cycle and grade it according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0 | Up to 3 years |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |