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| Name | Class |
|---|---|
| Anhui Provincial Hospital | OTHER_GOV |
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This study was a single-center, single-arm clinical study to evaluate the safety and efficacy of hypervision proton surgery with single large fractionated doses (34GyE and 39GyE) in the treatment of early peripheral NSCLC.
This study adopted a dose escalation protocol (an improved "two-stage two-dose group" design) to explore the safety and efficacy of visual proton surgery (single large fractionated doses of 34GyE and 39GyE) in the treatment of early peripheral NSCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proton radiotherpy | Experimental | Proton radiotherapy 34GyE/f or 39GyE/f |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypervision proton surgery | Radiation | Proton radiaotherapy (34GyE or 39GyE) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of grade ≥ 3 psAEs at 1 month | Radiation induced adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) | 1 month after proton radiotherapy |
| The incidence of grade ≥ 3 psAEs at 1 year | Radiation induced adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) | 1 year after proton radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Primary tumor control at 1 year | Primary tumor control at 1 year | 1 year after proton radiotherapy |
| Disease-free survival time | Disease-free survival time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuanghu Yuan, PhD | Contact | 0551-62894008 | yuanshuanghu@sina.com | |
| Li Li, PhD | Contact | 0551-62894008 | lililyde@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Shuanghu Yuan, PhD | Anhui Provincial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Hospital | Recruiting | Hefei | Anhui | 230001 | China |
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| Label | URL |
|---|---|
| A Randomized Phase 2 Study Comparing 2 Stereotactic Body Radiation Therapy Schedules for Medically Inoperable Patients With Stage I Peripheral Non-Small Cell Lung Cancer: NRG Oncology RTOG 0915 (NCCTG N0927) | View source |
| Long-term Follow-up on NRG Oncology RTOG 0915 (NCCTG N0927): A Randomized Phase 2 Study Comparing 2 Stereotactic Body Radiation Therapy Schedules for Medically Inoperable Patients With Stage I Peripheral Non-Small Cell Lung Cancer | View source |
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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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| From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
| Overall survival time | Overall survival time | From date of treatment until the date of death |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |