RISI in the Treatment of Recurrent Chest Wall Malignancies After EBRT

NCT04077710 | Unknown

• 1 other identifier: CNRBG-2019-CWM-RISI
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chest Wall Tumor

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (1)

• Overall survival time

  Outcomes will be followed up every 2-3 months after enrollment. The total follow-up time is 3 years.

Interventions

Radioactive Iodine-125 Seeds Implantation RADIATION

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Study Officials

• Junjie Wang, M.D. Ph.D

  Department of Radiation Oncology, Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhe Ji, M.D.

CONTACT

008618710002823; aschoff@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2019
• First Posted: September 4, 2019
• Study Start: May 1, 2020
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2025
• Last Updated: December 27, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Data will be available within 6 months of the study completion.
• Access Criteria: Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.

Locations

CN (1)