Safety and Efficacy of SBRT in the Treatment of Thoracic Malignant Tumors at Different Sites
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: stereotactic body radiation therapy.
- Who it may be relevant to
- Registry conditions: Radiotherapy, Thoracic Cancer, Safety and Efficacy. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Radiation stereotactic body radiation therapy
The patients were treated with high-dose and low fractionated radiotherapy, using modern precision radiotherapy technology.
Primary outcome measures
- Local progression free survival [Time frame: From the beginning of the treatment to 2 years after the treatment.]
- Toxicities [Time frame: From the beginning of the treatment to 2 years after the treatment.]
Secondary outcome measures (1)
- Overall survival [Time frame: From the beginning of the treatment to 2 years after the treatment.]
Eligibility criteria
Inclusion criteria
- Pathological diagnosis was malignant tumor.
- 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
- Poor basic pulmonary function or symptom correlation caused by various reasons, unable to lie flat or cooperate with treatment.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Peking University Third Hospital — Beijing
Identifiers
NCT: NCT05349552 · BYSY-2022-SBRT-LC