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

NCT05349552 | Recruiting

• 1 other identifier: BYSY-2022-SBRT-LC
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Radiotherapy; Thoracic Cancer; Safety and Efficacy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Overall survival

  From the beginning of the treatment to 2 years after the treatment.

Study Arms (4)

Chest Wall Type

The lesion is directly adjacent (less than 1cm) or overlapped with the chest wall.

Radiation: stereotactic body radiation therapy

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

Central Type

The lesion is less than 2cm away from the bronchial tree.

Radiation: stereotactic body radiation therapy

Ultral-central Type

The lesion is directly adjacent or overlapped with the mediastinal structure.

Radiation: stereotactic body radiation therapy

Interventions

stereotactic body radiation therapy RADIATION

The patients were treated with high-dose and low fractionated radiotherapy, using modern precision radiotherapy technology.

Central Type; Chest Wall Type; Peripheral Type; Ultral-central Type

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Zhe Ji, M.D.

CONTACT

008618710002823; aschoff@163.com

Junjie Wang, M.D.

CONTACT

008601082265921; junjiewang_edu@sina.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: April 27, 2022
• Study Start: May 1, 2022
• Primary Completion: April 30, 2025
• Study Completion (Estimated): April 30, 2027
• Last Updated: December 27, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Data will be available within 6 months of the study completion.
• Access Criteria: Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.

Locations

CN (1)