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

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.

Study Overview

• Status: Recruiting
• Conditions: Thoracic Cancer; Radiotherapy; Safety and Efficacy
• Intervention / Treatment: Radiation: stereotactic body radiation therapy

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Junjie Wang, M.D.; Phone Number: 008601082265921; Email: junjiewang_edu@sina.cn
• Study Contact Backup: Name: Zhe Ji, M.D.; Phone Number: 008618710002823; Email: aschoff@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Recruiting
      • Peking University Third Hospital
      • Contact: Junjie Wang, M.D.; Phone Number: 00861082265921; Email: junjiewang_edu@sina.cn
      • Contact: Zhe Ji, M.D.; Phone Number: 008618710002823; Email: aschoff@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with chest malignant tumors who received SBRT treatment in our department from 2022 to 2025 are expected to be enrolled.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chest Wall Type; The lesion is directly adjacent (less than 1cm) or overlapped with the chest wall.	Radiation: 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.	Radiation: 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.	Radiation: 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.	Radiation: stereotactic body radiation therapy; The patients were treated with high-dose and low fractionated radiotherapy, using modern precision radiotherapy technology.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: April 21, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 27, 2022

Study Record Updates

• Last Update Posted (Estimated): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 22, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: BYSY-2022-SBRT-LC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
• IPD Sharing Time Frame: Data will be available within 6 months of the study completion.
• IPD Sharing Access Criteria: Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No