RISI in the Treatment of Recurrent Chest Wall Malignancies After EBRT

December 22, 2023 updated by: Peking University Third Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local control time
Time Frame: 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.
Outcomes will be followed up every 2-3 months after enrollment. The total follow-up time is 3 years.
Incidence of adverse events
Time Frame: 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.
Outcomes will be followed up every 2-3 months after enrollment. The total follow-up time is 3 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival time
Time Frame: 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.
Outcomes will be followed up every 2-3 months after enrollment. The total follow-up time is 3 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Investigators

  • Principal Investigator: Junjie Wang, M.D. Ph.D, Department of Radiation Oncology, Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2020

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

September 1, 2019

First Submitted That Met QC Criteria

September 1, 2019

First Posted (Actual)

September 4, 2019

Study Record Updates

Last Update Posted (Estimated)

December 27, 2023

Last Update Submitted That Met QC Criteria

December 22, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNRBG-2019-CWM-RISI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data for all primary and secondary outcome measures will be made available.

IPD Sharing Time Frame

Data will be available within 6 months of the study completion.

IPD Sharing Access Criteria

Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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