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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05189054
Other study ID # BYSY-2021-SBRT-UC
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2022
Est. completion date April 30, 2027

Study information

Verified date October 2023
Source Peking University Third Hospital
Contact Zhe Ji, M.D.
Phone 008618710002823
Email aschoff@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date April 30, 2027
Est. primary completion date April 30, 2025
Accepts healthy volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China Peking University Third Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Toxcicties 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 3 years after the treatment.
Primary Local control time The time from the date of SBRT to the date of recurrence of the target tumor or the date of last observation. From the beginning of the treatment to 3 years after the treatment.
Secondary Overall survival time The time from the date of SBRT to the date of death from any cause or the date of last observation. From the beginning of the treatment to 3 years after the treatment.
Secondary Disease progression time The time from the date of SBRT to the date of disease progression from any cause or the date of last observation. From the beginning of the treatment to 3 years after the treatment.
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