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Recruiting NCT05189054

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

— Observational Stereotactic Body Radiation Therapy Irradiation; Reaction Thoracic Tumor Recurrent Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: stereotacitic body radiation therapy.
Who it may be relevant to
Registry conditions: Stereotactic Body Radiation Therapy, Irradiation; Reaction, Thoracic Tumor, Recurrent Cancer. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Toxcicties [Time frame: From the beginning of the treatment to 3 years after the treatment.]
  • Local control time [Time frame: From the beginning of the treatment to 3 years after the treatment.]
Secondary outcome measures (2)
  • Overall survival time [Time frame: From the beginning of the treatment to 3 years after the treatment.]
  • Disease progression time [Time frame: From the beginning of the treatment to 3 years after the treatment.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Peking University Third Hospital — Beijing

Identifiers

NCT: NCT05189054 · BYSY-2021-SBRT-UC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗