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

Radiotherapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05349552
• Other study ID #: BYSY-2022-SBRT-LC
• Status: Recruiting
• Start date: May 1, 2022
• Est. completion date: April 30, 2027

Study information

• Verified date: December 2023
• Source: Peking University Third Hospital
• Contact: Zhe Ji, M.D.
• Phone: 008618710002823
• Email: aschoff[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 30, 2027
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Radiotherapy
• Safety and Efficacy
• Thoracic Cancer

Intervention

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

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Secondary	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.