NCT05189054 Safety and Efficacy of SBRT in the Reirradiation for Ultra-central Thoracic Malignant Tumors
| NCT ID | NCT05189054 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking University Third Hospital |
| Condition | Stereotactic Body Radiation Therapy |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2022-05-01 |
| Primary Completion | 2025-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2022-05-01 with a primary completion date of 2025-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Junjie Wang, M.D.
PRINCIPAL INVESTIGATOR
Peking University Third Hospital
Frequently Asked Questions
Who can join the NCT05189054 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Stereotactic Body Radiation Therapy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05189054 currently recruiting?
Yes, NCT05189054 is actively recruiting participants. Contact the research team at aschoff@163.com for enrollment information.
Where is the NCT05189054 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05189054 clinical trial?
NCT05189054 is sponsored by Peking University Third Hospital. The principal investigator is Junjie Wang, M.D. at Peking University Third Hospital. The trial plans to enroll 40 participants.