RISI in the Treatment of Recurrent Chest Wall Malignancies After EBRT

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04077710
• Other study ID #: CNRBG-2019-CWM-RISI
• Status: Recruiting
• Start date: May 1, 2020
• Est. completion date: April 30, 2025

Study information

• Verified date: May 2023
• Source: Peking University Third Hospital
• Contact: Zhe Ji, M.D.
• Phone: 008618710002823
• Email: aschoff[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Chest Wall Tumor
• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

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.