BrachytherapyRISIRLCNCT04071418
I-125 Seeds Implantation in the Treatment of Recurrent Lung Cancer After Radiotherapy
An observational study of Brachytherapy and Non-small Cell Lung Cancer, run by Peking University Third Hospital at 1 site in China.
Trial summary
Patients with recurrence after radiotherapy are often encountered in clinical practice.Patients with recurrence after radiotherapy are less likely to undergo surgery or secondary radiotherapy, and the guidelines recommend only systemic therapy, although the effective rate is relatively low.For patients with local… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Brachytherapy, Non-small Cell Lung Cancer
- What is being tested?
- 3D-printing Template-assisted CT-guided I-125 Seeds Implantation
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2020to 30 Apr 2026
- How long will I take part?
- 2 Years
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with reccurent NSCLC after external beam radiotherapy who meet the criteria can be enrolled in the study.
Who may be able to join
- (1) Age 18-75 years old
- (2) Pathological diagnosis of NSCLC, recurrence after radiotherapy, lesion diameter less than 5 cm
- (3) No systemic metastasis or metastasis, metastasis has been controlled by pre-treatment
- (4) No bleeding tendency, anticoagulant therapy and/or anti-platelet coagulant drugs should be stopped for at least one week before seed implantation
- (5) No serious or uncontrolled underlying diseases (such as severe or uncontrolled high). Blood pressure, diabetes mellitus, cardiovascular and cerebrovascular diseases and organ dysfunction, etc.
- (6) There is a suitable puncture path, which is expected to achieve the therapeutic dose
- (7) KPS > 70 points, which is expected to be able to tolerate puncture/RISI therapy, and the expected survival time is longer than 3 months.
Who cannot join
- (1) Poor basic pulmonary function with severe emphysema, bullae and interstitial pneumonia
- (2) Liquefaction and necrosis in a large area near the mediastinum or focus, with high risk of puncture bleeding or poor seeds distribution
- (3) Infection and ulcer in puncture site
- (4) Pregnant women, lactating women, children and psychiatric patients
- (5) Patients who are participating in other clinical studies
- (6) Poor compliance, unable to complete the treatment
- (7) The researchers think that it is not appropriate 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 3D-printing Template Assisted CT-guided Radioactive I-125 Seeds Implantation in the Treatment of Recurrent Lung Cancer After External Beam Radiotherapy: a Multicenter, Prospective Cohort Study
Patients with recurrence after radiotherapy are often encountered in clinical practice.Patients with recurrence after radiotherapy are less likely to undergo surgery or secondary radiotherapy, and the guidelines recommend only systemic therapy, although the effective rate is relatively low.For patients with local recurrence without distant metastasis, local treatment is still significant.Radioactive I-125 Seed Implantation (RISI) treatment is to I-125 Radioactive nuclide directly inside the implanted tumors, make its rays to continuous destruction of tumor cells, have inside the tumor target high dose, low dose of normal tissue around, and its radiation is low dose rate, in theory, more conducive to the protection of the normal tissue, more suitable for salvage treatment of recurrence after radiotherapy lesions.Some retrospective studies on RISI treatment of NSCLC showed that the local control rate was up to 25%-80%, and there were few reports of toxic and side effects, suggesting that it had good efficiency and safety.Therefore, for patients with recurrent NSCLC after chest radiotherapy, RISI may be considered.And template technology, 3 d printing is a new kind of technology in recent years, can be individualized and human body surface, the guide posts on the the direction of the puncture needle can be accurately controlled, the current data show that in the template with CT guided by solid tumors as well had significantly higher accuracy, as the actual target dose of basic postoperative can reach the design request of the preoperative planning, so the application of 3D printing template helps to further improve the operation efficiency and safety, also has potential promotion effect to curative effect.The purpose of this study was: (1) to observe the efficacy, toxic and side effects of RISI in the treatment of recurrent NSCLC after radiotherapy under the guidance of 3D printing template assisted CT, and to evaluate its safety and effectiveness;(2) to explore the relationship between the efficacy, toxicity and side effects of RISI dose in the treatment of recurrent NSCLC after radiotherapy;(3) analyze the relevant influencing factors affecting the effect/toxicity of RISI in the treatment of recurrent NSCLC after radiotherapy.
Read the detailed description
The purpose of this study was to observe the efficacy and adverse reactions of RISI in the treatment of recurrent NSCLC after radiotherapy, and to evaluate its safety and efficacy.To explore the relationship between the efficacy, toxicity and side effects of recurrent NSCLC treated with different RISI doses after radiotherapy.To analyze the relevant influencing factors affecting the efficacy/toxicity of RISI in the treatment of recurrent NSCLC after radiotherapy.
This study is a non-randomized, prospective, single-arm, cohort study.Patients meeting the inclusion criteria were enrolled consecutively in the order of admission and treatment, and a total of 30 patients were expected to be enrolled.The therapeutic dose range of I-125 was 140-160Gy, and the prescribed dose was intended to be divided into 15 cases of 140-150Gy and 150-160Gy, respectively. The specific situation was subject to the actual postoperative verified dose.
- Conditions
- Brachytherapy, Non-small Cell Lung Cancer
- Being tested
- 3D-printing Template-assisted CT-guided I-125 Seeds Implantation
- Keywords
- recurrent lung cancer, I-125 seeds implantation, radiotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-printing Template-assisted CT-guided I-125 Seeds ImplantationRadiation
(1) positioning and preoperative plan design;(2) 3D printing template design and production;(3) reset and seeds implantation;(4) intraoperative optimization;Postoperative dose verification.Dosimetric parameters include: dose D90 and D100 reaching a certain percentage target volume; Target volume V100, V150 and V200 reaching a certain percentage of prescribed dose;And the dose of organs at risk: Dmean, D2cc, d0.5cc, d0.1cc. Regular follow-up was conducted after treatment.
| Study group | Role | What they receive |
|---|---|---|
| I-125 Seeds Implantation | All the enrolled patients were treated with CT-guided radioactive I-125 seeds implantation assisted by 3D printing template. Prescription dose 140-160gy. Receives: Radiation: 3D-printing Template-assisted CT-guided I-125 Seeds Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local tumor control rate
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 2 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 2 years.
Secondary outcomes (2)
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 2 years
Progression-free survival
The time between the beginning of treatment and the date of progression of the disease or the date of death for any reasons or the date of last observation.
Measured: Outcomes will be followed up every 2-3 months after enrollment. The total follow-up time is 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 May 2020
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BrachytherapyStudies 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)
- Target duration
- 2 Years
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
- NCT04071418
- Sponsor's protocol ID
- CNRBG-2019-RLC-RISI
- Acronym
- RISIRLC
- Status last verified
- May 2023
- First submitted
- 26 Aug 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 3D-printing Template Assisted CT-guided Radioactive I-125 Seeds Implantation in the Treatment of Recurrent Lung Cancer After External Beam Radiotherapy: a Multicenter, Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04071418
- Acronym / sponsor ID
- RISIRLC / CNRBG-2019-RLC-RISI
- Conditions
- Brachytherapy, Non-small Cell Lung Cancer
- Keywords
- recurrent lung cancer, I-125 seeds implantation, radiotherapy
- 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 2026 (estimated)
- First posted
- 28 Aug 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.
Patients with recurrence after radiotherapy are often encountered in clinical practice.Patients with recurrence after radiotherapy are less likely to undergo surgery or secondary radiotherapy, and the guidelines recommend only systemic therapy, although the effective rate is relatively low.For patients with local recurrence without distant metastasis, local treatment is still significant.Radioactive I-125 Seed Implantation (RISI) treatment is to I-125 Radioactive nuclide directly inside the implanted tumors, make its rays to continuous destruction of tumor cells, have inside the tumor target high dose, low dose of normal tissue around, and its radiation is low dose rate, in theory, more conducive to the protection of the normal tissue, more suitable for salvage treatment of recurrence after radiotherapy lesions.Some retrospective studies on RISI treatment of NSCLC showed that the local control rate was up to 25%-80%, and there were few reports of toxic and side effects, suggesting that it had good efficiency and safety.Therefore, for patients with recurrent NSCLC after chest radiotherapy, RISI may be considered.And template technology, 3 d printing is a new kind of technology in recent years, can be individualized and human body surface, the guide posts on the the direction of the puncture needle can be accurately controlled, the current data show that in the template with CT guided by solid tumors as well had significantly higher accuracy, as the actual target dose of basic postoperative can reach the design request of the preoperative planning, so the application of 3D printing template helps to further improve the operation efficiency and safety, also has potential promotion effect to curative effect.The purpose of this study was: (1) to observe the efficacy, toxic and side effects of RISI in the treatment of recurrent NSCLC after radiotherapy under the guidance of 3D printing template assisted CT, and to evaluate its safety and effectiveness;(2) to explore the relationship between the efficacy, toxicity and side effects of RISI dose in the treatment of recurrent NSCLC after radiotherapy;(3) analyze the relevant influencing factors affecting the effect/toxicity of RISI in the treatment of recurrent NSCLC after radiotherapy.
Detailed description
The purpose of this study was to observe the efficacy and adverse reactions of RISI in the treatment of recurrent NSCLC after radiotherapy, and to evaluate its safety and efficacy.To explore the relationship between the efficacy, toxicity and side effects of recurrent NSCLC treated with different RISI doses after radiotherapy.To analyze the relevant influencing factors affecting the efficacy/toxicity of RISI in the treatment of recurrent NSCLC after radiotherapy.
This study is a non-randomized, prospective, single-arm, cohort study.Patients meeting the inclusion criteria were enrolled consecutively in the order of admission and treatment, and a total of 30 patients were expected to be enrolled.The therapeutic dose range of I-125 was 140-160Gy, and the prescribed dose was intended to be divided into 15 cases of 140-150Gy and 150-160Gy, respectively. The specific situation was subject to the actual postoperative verified dose.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I-125 Seeds Implantation | – | Radiation: 3D-printing Template-assisted CT-guided I-125 Seeds ImplantationAll the enrolled patients were treated with CT-guided radioactive I-125 seeds implantation assisted by 3D printing template. Prescription dose 140-160gy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with reccurent NSCLC after external beam radiotherapy who meet the criteria can be enrolled in the study.
Key inclusion criteria (7 listed)
- (1) Age 18-75 years old
- (2) Pathological diagnosis of NSCLC, recurrence after radiotherapy, lesion diameter less than 5 cm
- (3) No systemic metastasis or metastasis, metastasis has been controlled by pre-treatment
- (4) No bleeding tendency, anticoagulant therapy and/or anti-platelet coagulant drugs should be stopped for at least one week before seed implantation
- (5) No serious or uncontrolled underlying diseases (such as severe or uncontrolled high). Blood pressure, diabetes mellitus, cardiovascular and cerebrovascular diseases and organ dysfunction, etc.
Key exclusion criteria (7 listed)
- (1) Poor basic pulmonary function with severe emphysema, bullae and interstitial pneumonia
- (2) Liquefaction and necrosis in a large area near the mediastinum or focus, with high risk of puncture bleeding or poor seeds distribution
- (3) Infection and ulcer in puncture site
- (4) Pregnant women, lactating women, children and psychiatric patients
- (5) Patients who are participating in other clinical studies
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 |
|---|---|---|
| 3D-printing Template-assisted CT-guided I-125 Seeds Implantation(1) positioning and preoperative plan design;(2) 3D printing template design and production;(3) reset and seeds implantation;(4) intraoperative optimization;Postoperative dose verification.Dosimetric parameters include: dose D90 and D100 reaching a certain percentage target volume; Target volume V100, V150 and V200 reaching a certain percentage of prescribed dose;And the dose of organs at risk: Dmean, D2cc, d0.5cc, d0.1cc. Regular follow-up was conducted after treatment. | Radiation | I-125 Seeds Implantation |
Primary outcome
Local tumor control rate
Time frame: Outcomes will be followed up every 2-3 months after enrollment. The total follow-up time is 2 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 2 years.
The adverse events are evaluated by the common terminology criteria for adverse events (CTCAE). The rate of each adverse event will be measured.
2 secondary outcomes
Overall survival time
Time frame: Outcomes will be followed up every 2-3 months after enrollment. The total follow-up time is 2 years
Progression-free survival
Time frame: Outcomes will be followed up every 2-3 months after enrollment. The total follow-up time is 2 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 Brachytherapy and Non-small Cell Lung Cancer, 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 7 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 tumor control rate (time frame: Outcomes will be followed up every 2-3 months after enrollment. The total follow-up time is 2 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.