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RISI in the Treatment of Recurrent Chest Wall Malignancies After EBRT

NCT ID: NCT04077710

Last Updated: 2023-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-01

Study Completion Date

2025-04-30

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.

Conditions

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Chest Wall Tumor

Keywords

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radioactive iodine-125 seeds implantation 3D-printing template chest wall malignancies

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type RADIATION

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Junjie Wang, M.D. Ph.D

Role: PRINCIPAL_INVESTIGATOR

Department of Radiation Oncology, Peking University Third Hospital

Locations

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Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhe Ji, M.D.

Role: CONTACT

Phone: 008618710002823

Email: [email protected]

Facility Contacts

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Zhe Ji, M.D.

Role: primary

Other Identifiers

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CNRBG-2019-CWM-RISI

Identifier Type: -

Identifier Source: org_study_id