RISI in the Treatment of Recurrent Chest Wall Malignancies After EBRT

Recruiting

• Conditions: Chest Wall Tumor

• Registration Number: NCT04077710
• Lead Sponsor: Peking University Third Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-09-01
• Study First Submitted QC: 2019-09-01
• Study First Posted: 2019-09-04
• Study Start: 2020-05-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-12-22
• Last Update Posted: 2023-12-27
• Primary Completion: 2024-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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