Cervical CancerNCT04127435
High Dose Rate Interstitial Brachytherapy With Three Dimensional Printing Template for Recurrent Gynecologic Tumors
An observational study of Cervical Cancer, run by Peking University Third Hospital at 2 sites in China.
Trial summary
This is a single-center study.Eligible patients will have histologically proven pelvic recurrence of cervical cancer after radiotherapy . Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Cervical Cancer
- How many people
- 50 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2019to 31 Dec 2020
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with histologically confirmed pelvic recurrence of cervical cancer.
Who may be able to join
- Patients with histologically confirmed pelvic recurrence of cervical cancer.
- Age ≥ 18 years and ≤ 75 years.
- Previous accept pelvic radiotherapy;
- Karnofsky ≥60；
- Patients reject or cannot tolerate surgery;
- Received 192Ir high dose rate intertissue salvage therapy;
- Ultrasound guidance or computed tomography guidance;
- Regular review and follow-up.
Who cannot join
- Patients participated in clinical trials of other drugs within four weeks;
- The patient had a previous history of bleeding, and any bleeding event with severity rating of CTCAE5.0 or above occurred within 4 weeks prior to screening;
- There are any puncture taboos.
- Patients with severe cardiovascular and cerebrovascular diseases.
- Unable to treat as planned.
- Patients lack major indicators and cannot participate in post-treatment review and follow-up.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Peking University Third Hospital
Beijing
junjie wang, MD,PhD, 13701076310, junjiewang_edu@sina.cn
- Not yet recruiting
Peking University Third Hospital
Beijing
Junjie Wang, MD,PhD, 13701076310, junjiewang_edu@sina.cn
About this study
Official title: Clinical Study on Pelvic Recurrence of Gynecologic Tumors After External Irradiation by Three Dimensional Printing Personalized Template Assisted With 192Ir High Dose Rate Interstitial Brachytherapy
This is a single-center study.Eligible patients will have histologically proven pelvic recurrence of cervical cancer after radiotherapy .
Read the detailed description
The results of treatment, examination and follow-up of patients with recurrent cervical cancer after radiotherapy who recieved imaging guided three dimensional printing personalized template assisted with 192Ir high dose rate interorganizational braided therapy were statistically analyzed .
- Conditions
- Cervical Cancer
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| High-Dose-Rate 192Ir Brachytherapy | 1. All patients underwent computed tomography (CT) 3-5 days before surgery. The collimation is 2.5 mm and CT Planning System. 2. Delineation of the gross tumor volume (GTV) and adjacent organs at risk (OARs); 3. Determination of the needle tract of the implanted insertion direction, distribution, and depth. Then calculation of the dose distribution of the target volume and OARs. 4. Depending on B-TPS data, we establish a digital model for the individual template. 5. Local anesthesia or intraspinal anesthesia was induced in all patients. The three-dimensional printing noncoplanar templates (3D-PNCT) was placed on the surface of the treatment area of the patient. The 3D-PNCT was aligned accurately with the outer-contour features. Through the guide hole of the 3D-PNCT, we inserted to pre-planned depths. 6. Delineation of the GTV and design planning . 7. Connect the source tube and 192Ir high dose rate interorganizational brinotherapy 8. At the end pressed to stop bleeding. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Progression Free Survival
Local progression free survival was defined as the time from the implantation of the treatment to the treatment of local tumor progression.
Measured: 2 years
Tumor Response Rate
Tumor size changes were monitored using CT. According to the solid tumor treatment efficacy evaluation standard RECIST, evaluation results including complete response, partial response, stable disease, and progression disease.Tumor response rate was complete response rate plus partial response rate.
Measured: three months
Secondary outcomes (2)
Overall survival
Overall survival was defined as the time from the implantation of the treatment to the death of any cause.
Measured: 2 years
Safety and Tolerability
Number of participants with treatment-related acute adverse events were evaluated according to RTOG acute radiation injury grading standards; Number of participants with treatment-related late adverse events were evaluated according to RTOG/ EORTC advanced radiation injury grading schemes.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start1 Jan 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical 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
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ping Jiang, MD, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04127435
- Sponsor's protocol ID
- M2019338-1
- Status last verified
- Aug 2019
- First submitted
- 1 Sep 2019
- Last updated
- 15 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Pelvic Recurrence of Gynecologic Tumors After External Irradiation by Three Dimensional Printing Personalized Template Assisted With 192Ir High Dose Rate Interstitial Brachytherapy
- ClinicalTrials.gov ID
- NCT04127435
- Acronym / sponsor ID
- M2019338-1
- Conditions
- Cervical Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 15 Oct 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 is a single-center study.Eligible patients will have histologically proven pelvic recurrence of cervical cancer after radiotherapy .
Detailed description
The results of treatment, examination and follow-up of patients with recurrent cervical cancer after radiotherapy who recieved imaging guided three dimensional printing personalized template assisted with 192Ir high dose rate interorganizational braided therapy were statistically analyzed .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-Dose-Rate 192Ir Brachytherapy | – | –1. All patients underwent computed tomography (CT) 3-5 days before surgery. The collimation is 2.5 mm and CT Planning System. 2. Delineation of the gross tumor volume (GTV) and adjacent organs at risk (OARs); 3. Determination of the needle tract of the implanted insertion direction, distribution, and depth. Then calculation of the dose distribution of the target volume and OARs. 4. Depending on B-TPS data, we establish a digital model for the individual template. 5. Local anesthesia or intraspinal anesthesia was induced in all patients. The three-dimensional printing noncoplanar templates (3D-PNCT) was placed on the surface of the treatment area of the patient. The 3D-PNCT was aligned accurately with the outer-contour features. Through the guide hole of the 3D-PNCT, we inserted to pre-planned depths. 6. Delineation of the GTV and design planning . 7. Connect the source tube and 192Ir high dose rate interorganizational brinotherapy 8. At the end pressed to stop bleeding. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with histologically confirmed pelvic recurrence of cervical cancer.
Key inclusion criteria (8 listed)
- Patients with histologically confirmed pelvic recurrence of cervical cancer.
- Age ≥ 18 years and ≤ 75 years.
- Previous accept pelvic radiotherapy;
- Karnofsky ≥60；
- Patients reject or cannot tolerate surgery;
Key exclusion criteria (6 listed)
- Patients participated in clinical trials of other drugs within four weeks;
- The patient had a previous history of bleeding, and any bleeding event with severity rating of CTCAE5.0 or above occurred within 4 weeks prior to screening;
- There are any puncture taboos.
- Patients with severe cardiovascular and cerebrovascular diseases.
- Unable to treat as planned.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Local Progression Free Survival
Time frame: 2 years
Local progression free survival was defined as the time from the implantation of the treatment to the treatment of local tumor progression.
Tumor Response Rate
Time frame: three months
Tumor size changes were monitored using CT. According to the solid tumor treatment efficacy evaluation standard RECIST, evaluation results including complete response, partial response, stable disease, and progression disease.Tumor response rate was complete response rate plus partial response rate.
2 secondary outcomes
Overall survival
Time frame: 2 years
Safety and Tolerability
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
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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.
Ping Jiang, MD principal investigator
Study Principal Investigator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer, run by Peking University Third Hospital at 2 sites 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 8 inclusion and 6 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 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Ping Jiang, MD (13439796018, drjiangping@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Progression Free Survival (time frame: 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 15 Oct 2019.