Chest Wall TumorNCT04077710
RISI in the Treatment of Recurrent Chest Wall Malignancies After EBRT
An observational study of Chest Wall Tumor, run by Peking University Third Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chest Wall Tumor
- What is being tested?
- Radioactive Iodine-125 Seeds Implantation
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2020to 30 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Zhe Ji, M.D., +8618710002823, aschoff@163.com
About this study
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
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.
Read the 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.
- Conditions
- Chest Wall Tumor
- Being tested
- Radioactive Iodine-125 Seeds Implantation
- Keywords
- radioactive iodine-125 seeds implantation, 3D-printing template, chest wall malignancies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radioactive Iodine-125 Seeds ImplantationRadiation
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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
The time from the date of seeds implantation to the date of death from any cause or the date of last observation.
Measured: Outcomes will be followed up every 2-3 months after enrollment. The total follow-up time is 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start1 May 2020
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest Wall TumorStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Junjie Wang, M.D. Ph.D, Principal investigator, Department of Radiation Oncology, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04077710
- Sponsor's protocol ID
- CNRBG-2019-CWM-RISI
- Status last verified
- May 2023
- First submitted
- 1 Sep 2019
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04077710
- Acronym / sponsor ID
- CNRBG-2019-CWM-RISI
- Conditions
- Chest Wall Tumor
- Keywords
- radioactive iodine-125 seeds implantation, 3D-printing template, chest wall malignancies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 4 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radioactive Iodine-125 Seeds ImplantationThe 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. | Radiation | – |
Primary outcome
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.
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.
1 secondary outcome
Overall survival time
Time frame: Outcomes will be followed up every 2-3 months after enrollment. The total follow-up time is 3 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junjie Wang, M.D. Ph.D principal investigator
Department of Radiation Oncology, Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chest Wall Tumor, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhe Ji, M.D. (008618710002823, aschoff@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2023.