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NCT Number: NCT05189054

Safety and Efficacy of SBRT in the Reirradiation for Ultra-central Thoracic Malignant Tumors

The reirradiation of thoracic tumor is difficult. The possibility of surgery or re course radiotherapy is very small. In the NCCN guideline, only systemic treatment is recommended. However, the effective rate of systemic treatment is low. SBRT has the characteristics of high dose in tumor target area and low dose in surrounding normal tissues. In theory, SBRT is more conducive to the protection of normal tissues and can potentially be used in the salvage treatment of recurrent lesions after radiotherapy. Even so, SBRT is still controversial in the rescue treatment of recurrent lung cancer after radiotherapy, especially for "ultral-central" lesions close to mediastinal structures (such as bronchus, esophagus and large blood vessels), which have a high probability of fatal side effects. However, a few studies on the application of SBRT in the reirradiation for ultral-central lung cancer have shown acceptable safety and efficacy. Generally speaking, there are few studies on SBRT in the treatment of recurrent ultral-central tumor with limited data. The purpose of this study is to further evaluate the efficacy and toxicities of SBRT in the treatment of recurrent ultral-central tumors after radiotherapy.

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Key information

Conditions

Stereotactic Body Radiation Therapy Disease Attributes Irradiation; Reaction Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Recurrent Cancer Thoracic Neoplasms Thoracic Tumor

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

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

Inclusion criteria

  • Pathological diagnosis is malignant tumor.
  • The location of the target lesion belongs to the ultra-central type of chest.
  • The target lesion had a history of radiotherapy, 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

stereotacitic body radiation therapy

Radiation

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

Primary outcomes

  1. Toxcicties

    Time frame: From the beginning of the treatment to 3 years after the treatment.

    Adverse events of radiation of normal tissues (Including lung, trachea, bronchus, esophagus, blood vessels, ribs, spinal cord, brachial plexus).

  2. Local control time

    Time frame: From the beginning of the treatment to 3 years after the treatment.

    The time from the date of SBRT to the date of recurrence of the target tumor or the date of last observation.

Secondary outcomes

  1. Overall survival time

    Time frame: From the beginning of the treatment to 3 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.

  2. Disease progression time

    Time frame: From the beginning of the treatment to 3 years after the treatment.

    The time from the date of SBRT to the date of disease progression 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
Jan 12, 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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