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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radioactive Iodine-125 Seeds Implantation | Radiation | 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. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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The patients with chest wall malignancies (primary or metastasis) who were treated with CT-guided radioactive iodine-125 seeds implantation assisted by 3D-printing template during 2019 to 2021 will included in the study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhe Ji, M.D. | Contact | 008618710002823 | aschoff@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Junjie Wang, M.D. Ph.D | Department of Radiation Oncology, Peking University Third Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Recruiting | Beijing | Beijing Municipality | 100191 | China |
De-identified individual participant data for all primary and secondary outcome measures will be made available.
Data will be available within 6 months of the study completion.
Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.
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