Rectum Cancer, RecurrentNCT03890926
The Physical Dosimetry Study and Preliminary Clinical Results of 3D-printing Non Co-planar Template Assisted With CT-guidance for Iodine-125 Seed Brachytherapy in Pelvic Recurrent Rectum Carcinoma After Surgery and External Beam Radiotherapy
An observational study of Rectum Cancer, Recurrent and Brachytherapy, Radioisotope, run by Peking University Third Hospital.
Trial summary
This study observes the efficacy and side effects of 3D-printing non co-planar template(3D-PNCT) assisted with CT-guidance for radioactive Iodine-125 seed(RIS) brachytherapy in pelvic recurrent rectum carcinoma 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 80 years
- Conditions the study is for
- Rectum Cancer, Recurrent, Brachytherapy, Radioisotope
- What is being tested?
- radioactive Iodine-125 seed implantation under the guidance of 3D template
- Type of treatment
- Surgery or procedure
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients with local recurrent rectal carcinoma who were treated with 3D-printing non co-planar template assisted with CT-guidance for Iodine-125 seed brachytherapy as a conventional treatment in Peking University Third Hospital during December 2015 to December 2018
Who may be able to join
- treated with 3D-printing non co-planar template assisted with CT-guidance for Iodine-125 seed brachytherapy in Peking University Third Hospital
- histological proven recurrent rectal cancer
- inoperable local recurrent cases
- previous external beam radiotherapy, incapable of re-irradiation
- expected life span>3 months
Who cannot join
- serious medical illness
- unable to tolerate anesthesia
- blood coagulation dysfunction
About this study
Official title: The Physical Dosimetry Study and Preliminary Clinical Results of 3D-printing Non Co-planar Template Assisted With CT-guidance for Iodine-125 Seed Brachytherapy in Pelvic Recurrent Rectum Carcinoma After Surgery and External Beam Radiotherapy, a Retrospective Study
This study observes the efficacy and side effects of 3D-printing non co-planar template(3D-PNCT) assisted with CT-guidance for radioactive Iodine-125 seed(RIS) brachytherapy in pelvic recurrent rectum carcinoma retrospectively, and analyzes the influence of clinical and dosimetric factors on the outcomes.
Read the detailed description
3D-PNCT assisted with CT-guidance for 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. 3D-printing non co-planar template is made individually which guides the implantation of Iodine-125 seed into the tumor and ensures the accuracy of the position.This study collects the data of patients with pelvic recurrent rectal carcinoma who underwent 3D-PNCT assisted with CT-guidance for radioactive Iodine-125 seed implantation from 2015 to 2018. We evaluate the dose that covers 90% target volume(D90),the volume that 100% prescription dose covers(V100) and other dosimetric parameters after the implantation. The efficacy and adverse effects were observed. Local control(LC) time and overall survival(OS) time are evaluated.
- Being tested
- radioactive Iodine-125 seed implantation under the guidance of 3D template
- Keywords
- Three-Dimensional Printing, Rectum Cancer, Recurrent, Radioactive Iodine-125 seed implantation
- Medical subject headings
- Rectal Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radioactive Iodine-125 seed implantation under the guidance of 3D templateRadiation
3D-PNCT assisted with CT-guidance for radioactive Iodine-125 seed brachytherapy is a conventional treatment for patients with local recurrent rectal carcinoma. Retrospective data on the effectiveness and adverse effects of the past radioactive Iodine-125 seed implantation is collected.
| Study group | Role | What they receive |
|---|---|---|
| radioactive Iodine-125 seed implantation | All enrolled patients received the intervention previously as a conventional treatment. Receives: Radiation: radioactive Iodine-125 seed implantation under the guidance of 3D template |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival time
The time from the date of implantation to the date of death from any cause or the date of last observation. Outcomes were followed up every 3 months after enrollment.
Measured: From date of implantation to the date of death from any cause or the date of last observation. The last follow-up timepoint is February 2019.
Local control time
The time from the date of implantation to the date of recurrence of the implanted tumor or the date of last observation. Outcomes were followed up every 3 months after enrollment.
Measured: From date of implantation to the date of recurrence of the implanted tumor or the date of last observation. The last follow-up timepoint is February 2019.
Secondary outcomes (2)
Pain relief rate
Numerical rating scales(NRS) was used to evaluate the grade of pain. Grade 7-9 was defined as serve pain. Grade 4-6 was defined as moderate pain and grade 1-3 was defined as mild pain. The pain before and after the implantation was evaluated and the pain relief rate was measured.
Measured: 3 months after the implantation. The last follow-up point is February 2019.
Incidence of adverse events
The adverse events were evaluated by the toxicity criteria of the Radiation Therapy Oncology Group (RTOG). The rate of each adverse event was measured.
Measured: From date of implantation to the date of death from any cause or the date of last observation. 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 posted26 Mar 2019
- Study startDec 2015
- Primary completionFeb 2019
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rectum Cancer, RecurrentStudies 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
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- junjie wang, Ph.D, Principal investigator, Radiotherapy Department,Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03890926
- Sponsor's protocol ID
- PekingUTH RT
- Status last verified
- Mar 2019
- First submitted
- 9 Mar 2019
- Last updated
- 26 Mar 2019
- Results posted
- 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.
Publications
Wang Z, Lu J, Liu L, Liu T, Chen K, Liu F, Huang G. Clinical application of CT-guided (125)I seed interstitial implantation for local recurrent rectal carcinoma. Radiat Oncol. 2011 Oct 18;6:138. doi: 10.1186/1748-717X-6-138.
PubMed 22004599Wang L, Wang H, Jiang Y, Ji Z, Guo F, Jiang P, Li X, Chen Y, Sun H, Fan J, Li W, Li X, Wang J. The efficacy and dosimetry analysis of CT-guided 125I seed implantation assisted with 3D-printing non-co-planar template in locally recurrent rectal cancer. Radiat Oncol. 2020 Jul 25;15(1):179. doi: 10.1186/s13014-020-01607-2.
PubMed 32711542
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Physical Dosimetry Study and Preliminary Clinical Results of 3D-printing Non Co-planar Template Assisted With CT-guidance for Iodine-125 Seed Brachytherapy in Pelvic Recurrent Rectum Carcinoma After Surgery and External Beam Radiotherapy, a Retrospective Study
- ClinicalTrials.gov ID
- NCT03890926
- Acronym / sponsor ID
- PekingUTH RT
- Keywords
- Three-Dimensional Printing, Rectum Cancer, Recurrent, Radioactive Iodine-125 seed implantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Feb 2019 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 26 Mar 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 3D-printing non co-planar template(3D-PNCT) assisted with CT-guidance for radioactive Iodine-125 seed(RIS) brachytherapy in pelvic recurrent rectum carcinoma retrospectively, and analyzes the influence of clinical and dosimetric factors on the outcomes.
Detailed description
3D-PNCT assisted with CT-guidance for 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. 3D-printing non co-planar template is made individually which guides the implantation of Iodine-125 seed into the tumor and ensures the accuracy of the position.This study collects the data of patients with pelvic recurrent rectal carcinoma who underwent 3D-PNCT assisted with CT-guidance for radioactive Iodine-125 seed implantation from 2015 to 2018. We evaluate the dose that covers 90% target volume(D90),the volume that 100% prescription dose covers(V100) and other dosimetric 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 |
|---|---|---|
| radioactive Iodine-125 seed implantation | – | Radiation: radioactive Iodine-125 seed implantation under the guidance of 3D templateAll enrolled patients received the intervention previously as a conventional treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients with local recurrent rectal carcinoma who were treated with 3D-printing non co-planar template assisted with CT-guidance for Iodine-125 seed brachytherapy as a conventional treatment in Peking University Third Hospital during December 2015 to December 2018
Key inclusion criteria (5 listed)
- treated with 3D-printing non co-planar template assisted with CT-guidance for Iodine-125 seed brachytherapy in Peking University Third Hospital
- histological proven recurrent rectal cancer
- inoperable local recurrent cases
- previous external beam radiotherapy, incapable of re-irradiation
- expected life span>3 months
Key exclusion criteria (3 listed)
- serious medical illness
- unable to tolerate anesthesia
- blood coagulation dysfunction
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 seed implantation under the guidance of 3D template3D-PNCT assisted with CT-guidance for radioactive Iodine-125 seed brachytherapy is a conventional treatment for patients with local recurrent rectal carcinoma. Retrospective data on the effectiveness and adverse effects of the past radioactive Iodine-125 seed implantation is collected. | Radiation | radioactive Iodine-125 seed implantation |
Primary outcome
Overall survival time
Time frame: From date of implantation to the date of death from any cause or the date of last observation. The last follow-up timepoint is February 2019.
The time from the date of implantation to the date of death from any cause or the date of last observation. Outcomes were followed up every 3 months after enrollment.
Local control time
Time frame: From date of implantation to the date of recurrence of the implanted tumor or the date of last observation. The last follow-up timepoint is February 2019.
The time from the date of implantation to the date of recurrence of the implanted tumor or the date of last observation. Outcomes were followed up every 3 months after enrollment.
2 secondary outcomes
Pain relief rate
Time frame: 3 months after the implantation. The last follow-up point is February 2019.
Incidence of adverse events
Time frame: From date of implantation to the date of death from any cause or the date of last observation. 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 26 Mar 2019.
- Background: PubMed 22004599Wang Z, Lu J, Liu L, Liu T, Chen K, Liu F, Huang G. Clinical application of CT-guided (125)I seed interstitial implantation for local recurrent rectal carcinoma. Radiat Oncol. 2011 Oct 18;6:138. doi: 10.1186/1748-717X-6-138.
- Derived from this study: PubMed 32711542Wang L, Wang H, Jiang Y, Ji Z, Guo F, Jiang P, Li X, Chen Y, Sun H, Fan J, Li W, Li X, Wang J. The efficacy and dosimetry analysis of CT-guided 125I seed implantation assisted with 3D-printing non-co-planar template in locally recurrent rectal cancer. Radiat Oncol. 2020 Jul 25;15(1):179. doi: 10.1186/s13014-020-01607-2.
- 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, Ph.D principal investigator
Radiotherapy Department,Peking University Third Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Rectum Cancer, Recurrent and Brachytherapy, Radioisotope, 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 5 inclusion and 3 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 26 Mar 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?
Overall survival time (time frame: From date of implantation to the date of death from any cause or the date of last observation. 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?
On the ClinicalTrials.gov record for NCT03890926, which also lists 2 linked publications.
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 26 Mar 2019.