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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05189054
Enrollment
40
Registered
2022-01-12
Start date
2022-05-01
Completion date
2027-04-30
Last updated
2023-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irradiation; Reaction, Recurrent Cancer, Stereotactic Body Radiation Therapy, Thoracic Tumor

Brief summary

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

RADIATIONstereotacitic body radiation therapy

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

Sponsors

Peking University Third Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Local control timeFrom 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.
ToxcictiesFrom 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).

Secondary

MeasureTime frameDescription
Overall survival timeFrom 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.
Disease progression timeFrom 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.

Countries

China

Contacts

Primary ContactZhe Ji, M.D.
aschoff@163.com008618710002823
Backup ContactJunjie Wang, M.D.
junjiewang_edu@sina.cn008601082265921

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026