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

Recruiting

• Conditions: Stereotactic Body Radiation Therapy; Irradiation; Reaction; Recurrent Cancer; Thoracic Tumor

• Registration Number: NCT05189054
• Lead Sponsor: Peking University Third Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-26
• Study First Submitted QC: 2021-12-26
• Study First Posted: 2022-01-12
• Study Start: 2022-05-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-12-22
• Last Update Posted: 2023-12-27
• Primary Completion: 2025-04-30
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Local control time	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.
Toxcicties	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).

Secondary Outcome Measures

Name	Time	Method
Overall survival time	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.
Disease progression time	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.

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China