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Clinical Trials in China / NCT05349552
Recruiting Observational

Safety and Efficacy of SBRT in the Treatment of Thoracic Malignant Tumors at Different Sites

NCT05349552 · tracked via the Priya Life Science China tracker
Sponsor
Peking University Third Hospital
Phase
Observational
Started
2022-05-01
Last updated
2023-12-27

Condition(s) studied

RadiotherapyThoracic CancerSafety and Efficacy

Investigational drug(s) / intervention(s)

stereotactic body radiation therapy

stereotactic body radiation therapy: The patients were treated with high-dose and low fractionated radiotherapy, using modern precision radiotherapy technology.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Local progression free survival — From the beginning of the treatment to 2 years after the treatment.
    The time from the date of SBRT to the date of local recurrence or death or the date of last observation.
  • Toxicities — From the beginning of the treatment to 2 years after the treatment.
    Adverse events of radiation of normal tissues (Including lung, trachea, bronchus, esophagus, blood vessels, ribs, spinal cord, brachial plexus).

Trial sites (1)

FacilityCityRegionStatus
Peking University Third Hospital Beijing Beijing Municipality Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05349552 on ClinicalTrials.gov ↗ ← All trials in China