Early Stage Non-small Cell Lung CancerNCT03916367
CT-guided Radioactive I-125 Seeds Implantation for Early Stage Lung Cancer
An observational study of Early Stage Non-small Cell Lung Cancer, run by Peking University Third Hospital.
Trial summary
This study observes the efficacy and side effects of CT-guided radioactive iodine-125 seed brachytherapy in inoperable early stage non-small cell lung cancer retrospectively, and analyzes the influence of clinical and dosimetric factors on the outcomes. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Early Stage Non-small Cell Lung Cancer
- What is being tested?
- CT-guided Radioactive I-125 Seeds Implantation
- Type of treatment
- Surgery or procedure
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2010to 15 Feb 2019
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients with early stage non-small cell lung cancer who were treated with CT-guided radioactive iodine-125 seeds implantation during December 2010 to December 2018 were included in the study.
Who may be able to join
- histological proven non-small cell lung cancer
- UICC (Union for International Cancer Control) stage was T1-3N0M0 (stage Ia-IIb)
- inoperable and CT-guided radioactive iodine-125 seeds brachytherapy was used as the initial treatment without external beam radiotherapy
Who cannot join
- actual dose of covers 90% target volume (D90) less than 100 Gy in postoperative validation
- case information and/or follow-up information was unavailable
About this study
Official title: Clinical Outcome of CT-guided Radioactive Iodine-125 Seeds Implantation for Inoperable Early Stage Non-small Cell Lung Cancer
This study observes the efficacy and side effects of CT-guided radioactive iodine-125 seed brachytherapy in inoperable early stage non-small cell lung cancer retrospectively, 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 collects the data of patients with early stage (stage I-II, N0) non-small cell lung cancer who underwent CT-guided radioactive Iodine-125 seed implantation from 2010 to 2018. The investigators evaluate the dose that covers 90% target volume(D90) and other parameters after the implantation. The efficacy and adverse effects were observed. Local control(LC) time and overall survival(OS) time are evaluated.
- Conditions
- Early Stage Non-small Cell Lung Cancer
- Being tested
- CT-guided Radioactive I-125 Seeds Implantation
- Keywords
- radioactive iodine-125 seeds implantation, non-small cell lung cancer, early stage
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-guided Radioactive I-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.
| Study group | Role | What they receive |
|---|---|---|
| Early Stage Lung Cancer | The patients with early stage non-small cell lung cancer who were treated with CT-guided radioactive iodine-125 seeds implantation during December 2010 to December 2018. Receives: Radiation: CT-guided Radioactive I-125 Seeds Implantation |
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 were followed up every 3 months after enrollment. The last follow-up timepoint is February 2019.
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 were followed up every 3 months after enrollment. The last follow-up timepoint is February 2019.
Secondary outcomes (1)
Incidence of adverse events
The adverse events were evaluated by the common terminology criteria for adverse events (CTCAE). The rate of each adverse event was measured.
Measured: Outcomes were followed up every 3 months after seeds implantation. The last follow-up timepoint is February 2019.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start15 Dec 2010
- Primary completion15 Dec 2018
- Study completion15 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Stage Non-small Cell Lung CancerStudies 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
- Retrospective
- Enrolment
- 39 participants (actual)
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
- NCT03916367
- Sponsor's protocol ID
- CNRBG-81532-ESNSCLC-RISI
- Status last verified
- Apr 2019
- First submitted
- 12 Apr 2019
- Last updated
- 21 May 2019
- 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 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome of CT-guided Radioactive Iodine-125 Seeds Implantation for Inoperable Early Stage Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03916367
- Acronym / sponsor ID
- CNRBG-81532-ESNSCLC-RISI
- Conditions
- Early Stage Non-small Cell Lung Cancer
- Keywords
- radioactive iodine-125 seeds implantation, non-small cell lung cancer, early stage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 15 Dec 2010 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 15 Feb 2019 (actual)
- First posted
- 16 Apr 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 observes the efficacy and side effects of CT-guided radioactive iodine-125 seed brachytherapy in inoperable early stage non-small cell lung cancer retrospectively, 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 collects the data of patients with early stage (stage I-II, N0) non-small cell lung cancer who underwent CT-guided radioactive Iodine-125 seed implantation from 2010 to 2018. The investigators evaluate the dose that covers 90% target volume(D90) and other parameters after the implantation. The efficacy and adverse effects were observed. Local control(LC) time and overall survival(OS) time are evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Early Stage Lung Cancer | – | Radiation: CT-guided Radioactive I-125 Seeds ImplantationThe patients with early stage non-small cell lung cancer who were treated with CT-guided radioactive iodine-125 seeds implantation during December 2010 to December 2018. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients with early stage non-small cell lung cancer who were treated with CT-guided radioactive iodine-125 seeds implantation during December 2010 to December 2018 were included in the study.
Key inclusion criteria (3 listed)
- histological proven non-small cell lung cancer
- UICC (Union for International Cancer Control) stage was T1-3N0M0 (stage Ia-IIb)
- inoperable and CT-guided radioactive iodine-125 seeds brachytherapy was used as the initial treatment without external beam radiotherapy
Key exclusion criteria (2 listed)
- actual dose of covers 90% target volume (D90) less than 100 Gy in postoperative validation
- case information and/or follow-up information was unavailable
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 |
|---|---|---|
| CT-guided Radioactive I-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. | Radiation | Early Stage Lung Cancer |
Primary outcome
Local control time
Time frame: Outcomes were followed up every 3 months after enrollment. The last follow-up timepoint is February 2019.
The time from the date of seeds implantation to the date of recurrence of the implanted tumor or the date of last observation.
Overall survival time
Time frame: Outcomes were followed up every 3 months after enrollment. The last follow-up timepoint is February 2019.
The time from the date of seeds implantation to the date of death from any cause or the date of last observation.
1 secondary outcome
Incidence of adverse events
Time frame: Outcomes were followed up every 3 months after seeds implantation. The last follow-up timepoint is February 2019.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
- 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
Questions about this trial
What is this clinical trial studying?
An observational study of Early Stage Non-small Cell Lung Cancer, run by Peking University Third Hospital.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 21 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local control time (time frame: Outcomes were followed up every 3 months after enrollment. The last follow-up timepoint is February 2019.). 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 21 May 2019.