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SBRT (stereotactic radiotherapy) can provide a higher dose to the target area without increasing the risk of surrounding normal tissue / organ injury in selective cases. At present, SBRT has been widely used in radiotherapy of lung cancer and it can also play a better local control for lung metastasis.
However, there are parallel organs and series organs in the chest, and different organs have different tolerance to radiotherapy, so the toxicities of SBRT in different sites are different, and the prescription dose is also different.
This study intends to make a detailed division of the chest region and explore the safety and efficacy of SBRT in different areas. It is divided into four types: chest wall type: the lesion is directly adjacent or overlapped with the chest wall; peripheral type: the lesion is more than 1cm away from the chest wall and more than 2cm away from the bronchial tree; central type: the lesion is less than 2cm away from the bronchial tree; ultral-central type: the lesion is directly adjacent or overlapped with the mediastinal structure.
48-60Gy / 4-10f (EQD2 = 62.5Gy ~ 99.7Gy) was given according to the location of the tumor. Main outcome measures are local progression free survival and radiation toxicities; secondary outcome measure is overall survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chest Wall Type | The lesion is directly adjacent (less than 1cm) or overlapped with the chest wall. |
| |
| Peripheral Type | The lesion is more than 1cm away from the chest wall and more than 2cm away from the bronchial tree. |
| |
| Central Type | The lesion is less than 2cm away from the bronchial tree. |
| |
| Ultral-central Type | The lesion is directly adjacent or overlapped with the mediastinal structure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stereotactic body radiation therapy | Radiation | The patients were treated with high-dose and low fractionated radiotherapy, using modern precision radiotherapy technology. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Local progression free survival | The time from the date of SBRT to the date of local recurrence or death or the date of last observation. | From the beginning of the treatment to 2 years after the treatment. |
| Toxicities | Adverse events of radiation of normal tissues (Including lung, trachea, bronchus, esophagus, blood vessels, ribs, spinal cord, brachial plexus). | From the beginning of the treatment to 2 years after the treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | The time from the date of SBRT to the date of death from any cause or the date of last observation. | From the beginning of the treatment to 2 years after the treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with chest malignant tumors who received SBRT treatment in our department from 2022 to 2025 are expected to be enrolled.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhe Ji, M.D. | Contact | 008618710002823 | aschoff@163.com | |
| Junjie Wang, M.D. | Contact | 008601082265921 | junjiewang_edu@sina.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Recruiting | Beijing | Beijing Municipality | 100191 | China |
De-identified individual participant data for all primary and secondary outcome measures will be made available.
Data will be available within 6 months of the study completion.
Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |