RISI in the Treatment of Recurrent Chest Wall Malignancies After EBRT

Study Overview
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Brief Summary
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This study will observe the efficacy and toxicities of 3-dimensional printing noncoplanar template assisted CT guided radioactive iodine-125 seeds implantation in the treatment of patients with recurrent chest wall malignancies after external beam radiotherapy prospectively, and analyzes the influence of clinical and dosimetric factors on the outcomes.

Detailed Description
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Radioactive Iodine-125 seed brachytherapy is a conventional treatment in Peking University Third Hospital. Radioactive Iodine-125 seed brachytherapy is the implantation of Iodine-125 seed into tumors.The radioactive Iodine-125 seed can release low dose of irradiation persistently which kills tumors cell and causes less damage to normal tissue at the same time. This study will enroll the patients with recurrent chest wall malignancies after external beam radiotherapy (primary or metastasis) who underwent CT-guided radioactive iodine-125 seed implantation assisted by 3D-printing template from 2019 to 2021. The investigators evaluate the dose that covers 90% target volume(D90) and other parameters after the implantation. The efficacy and adverse events will be observed. Local control(LC) time and overall survival(OS) time are evaluated.

Official Title
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Safety and Efficacy of Three-dimensional Printing Template-assisted CT-guided Radioactive Iodine-125 Seeds Implantation in the Treatment of Recurrent Chest Wall Malignancies After External Beam Radiotherapy

Conditions
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Chest Wall Tumor

Intervention / Treatment
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* Radiation: Radioactive Iodine-125 Seeds Implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histological proven malignant tumor tumor located in chest wall and lesion diameter <= 10 cm recurrence after external beam radiotherapy there is no bleeding tendency there are no serious or uncontrolled underlying diseases (such as severe or uncontrolled hypertension, diabetes, cardiovascular and cerebrovascular diseases, and/or organ dysfunction there is an appropriate puncture path which is expected to achieve the treatment dose KPS > 70, which is expected to be able to tolerate puncture/ brachytherapy, and the expected survival time is longer than 3 months Exclusion Criteria: there are skin ulceration, or with high risk of skin infection and ulceration liquefaction and necrosis in a large area in tumor with poor expected seeds distribution pregnant women, lactating women, psychiatric patients patients with poor compliance can not complete the treatment patients that researchers considered inappropriate to participate in this clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: Radioactive Iodine-125 Seeds Implantation|The radioactive Iodine-125 seed can release low dose of irradiation persistently which kills tumors cell and causes less damage to normal tissue at the same time. The treatment was performed under CT monitoring. 3D-printing template includes information on the path of the implantation needle, characteristics of the surface of the therapy area of the patient, and positioning and orientation effects which can make the operation more accurate.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local control time | The time from the date of seeds implantation to the date of recurrence of the implanted tumor or the date of last observation. | Outcomes will be followed up every 2-3 months after enrollment. The total follow-up time is 3 years. | 
| Incidence of adverse events | The adverse events are evaluated by the common terminology criteria for adverse events (CTCAE). The rate of each adverse event will be measured. | Outcomes will be followed up every 2-3 months after enrollment. The total follow-up time is 3 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival time | The time from the date of seeds implantation to the date of death from any cause or the date of last observation. | Outcomes will be followed up every 2-3 months after enrollment. The total follow-up time is 3 years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radioactive iodine-125 seeds implantation, 3D-printing template, chest wall malignancies