Chest Wall Tumor Clinical Trial
Official title:
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
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | April 30, 2025 |
Est. primary completion date | April 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Peking University Third Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University Third Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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 | 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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