Safety and Efficacy of SBRT in the Treatment of Thoracic Malignant Tumors at Different Sites
NCT ID: NCT05349552
Last Updated: 2023-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
120 participants
OBSERVATIONAL
2022-05-01
2027-04-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Chest Wall Type
The lesion is directly adjacent (less than 1cm) or overlapped with the chest wall.
stereotactic body radiation therapy
The patients were treated with high-dose and low fractionated radiotherapy, using modern precision radiotherapy technology.
Peripheral Type
The lesion is more than 1cm away from the chest wall and more than 2cm away from the bronchial tree.
stereotactic body radiation therapy
The patients were treated with high-dose and low fractionated radiotherapy, using modern precision radiotherapy technology.
Central Type
The lesion is less than 2cm away from the bronchial tree.
stereotactic body radiation therapy
The patients were treated with high-dose and low fractionated radiotherapy, using modern precision radiotherapy technology.
Ultral-central Type
The lesion is directly adjacent or overlapped with the mediastinal structure.
stereotactic body radiation therapy
The patients were treated with high-dose and low fractionated radiotherapy, using modern precision radiotherapy technology.
Interventions
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stereotactic body radiation therapy
The patients were treated with high-dose and low fractionated radiotherapy, using modern precision radiotherapy technology.
Eligibility Criteria
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Inclusion Criteria
* The location of the target lesion belongs to one of five types and the lesion diameter is ≤ 5cm.
* There is no extensive systemic metastasis or although there is metastasis, the metastasis have been controlled by previous treatment.
* KPS\>70, no serious or uncontrolled underlying diseases, such as severe or uncontrolled hypertension, diabetes, cardiovascular and cerebrovascular diseases and organ dysfunction, and patients are expected to be tolerated by radiotherapy.
Exclusion Criteria
* The general condition is poor, and the expected survival time is less than 3 months.
* Psychiatric patients or poor compliance, unable to cooperate to complete treatment.
* For other reasons, the researcher believes that it is not suitable to participate in this trial.
18 Years
80 Years
ALL
No
Sponsors
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Peking University Third Hospital
OTHER
Responsible Party
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Locations
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Peking University Third Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Junjie Wang, M.D.
Role: primary
Zhe Ji, M.D.
Role: backup
Other Identifiers
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BYSY-2022-SBRT-LC
Identifier Type: -
Identifier Source: org_study_id