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NCT Number: NCT05349552

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.

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Key information

Conditions

Radiotherapy Safety and Efficacy Thoracic Cancer

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stereotactic Body Radiation Therapy

Radiation

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

Primary outcomes

  1. Local progression free survival

    Time frame: 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.

  2. Toxicities

    Time frame: 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).

Secondary outcomes

  1. Overall survival

    Time frame: From the beginning of the treatment to 2 years after the treatment.

    The time from the date of SBRT to the date of death from any cause or the date of last observation.

Study contacts

Contact information is provided by the study sponsor or research team.

Junjie Wang, M.D.

CONTACT

[email protected]

008601082265921

Zhe Ji, M.D.

CONTACT

[email protected]

008618710002823

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2027
First posted
Apr 27, 2022
Registry last updated
Dec 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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