BrachytherapyRetroBTNCT05242861
Retrospective Study of Brachytherapy
An observational study of Brachytherapy and Uterine Cervical Neoplasms, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
Brachytherapy for gynecological cancers will be studied retrospectively. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Brachytherapy, Uterine Cervical Neoplasms, Uterine Neoplasms
- What is being tested?
- Brachytherapy
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2022to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 18 to 80 years old female who diagnosed as gynecological cancer and underwent brachytherapy will be enrolled in this study.
Who may be able to join
- 18 - 80 female
- Underwent brachytherapy
- With gynecological cancer
Who cannot join
- Refusal to enter this trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Xiang Zhang, 0086-571-88122048, zhangxiang@zjcc.org.cn
Xiang Zhang
About this study
Official title: A Retrospective Study of Brachytherapy in Gynecological Cancers
Brachytherapy for gynecological cancers will be studied retrospectively.
- Conditions
- Brachytherapy, Uterine Cervical Neoplasms, Uterine Neoplasms, Vulvar Cancer, Vaginal Cancer, Ovarian Neoplasms
- Being tested
- Brachytherapy
- Keywords
- Brachytherapy, Cervical Cancer, Endometrial Cancer, Vaginal Cancer, Vulvar Cancer, Image Guided, 3D Print
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Neoplasms, Vulvar Neoplasms, Vaginal Neoplasms, Ovarian Neoplasms, Genital Neoplasms, Female, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrachytherapyRadiation
Applicator, dose, schedule, technology, image, 3D print, efficacy, toxicity of brachytherapy
| Study group | Role | What they receive |
|---|---|---|
| Cervix radical BT | Not described Receives: Radiation: Brachytherapy | |
| Cervix adjuvant BT | Not described Receives: Radiation: Brachytherapy | |
| Cervix palliative BT | Not described Receives: Radiation: Brachytherapy | |
| Uterus BT | Not described Receives: Radiation: Brachytherapy | |
| Other GO cancer BT | Not described Receives: Radiation: Brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival rate
the percentage of participants in the group who survives
Measured: 5-year
Secondary outcomes (2)
Progression-free survival rate
the percentage of participants in the group whose disease is likely to remain stable
Measured: 5-year
Side effects
side effects associated with treatment
Measured: 5-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start20 Feb 2022 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for BrachytherapyStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05242861
- Sponsor's protocol ID
- BTOG 2201
- Acronym
- RetroBT
- Status last verified
- Feb 2022
- First submitted
- 6 Feb 2022
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sturdza A, Potter R, Fokdal LU, Haie-Meder C, Tan LT, Mazeron R, Petric P, Segedin B, Jurgenliemk-Schulz IM, Nomden C, Gillham C, McArdle O, Van Limbergen E, Janssen H, Hoskin P, Lowe G, Tharavichitkul E, Villafranca E, Mahantshetty U, Georg P, Kirchheiner K, Kirisits C, Tanderup K, Lindegaard JC. Image guided brachytherapy in locally advanced cervical cancer: Improved pelvic control and survival in RetroEMBRACE, a multicenter cohort study. Radiother Oncol. 2016 Sep;120(3):428-433. doi: 10.1016/j.radonc.2016.03.011. Epub 2016 Apr 29.
PubMed 27134181Lindegaard JC, Madsen ML, Traberg A, Meisner B, Nielsen SK, Tanderup K, Spejlborg H, Fokdal LU, Norrevang O. Individualised 3D printed vaginal template for MRI guided brachytherapy in locally advanced cervical cancer. Radiother Oncol. 2016 Jan;118(1):173-5. doi: 10.1016/j.radonc.2015.12.012. Epub 2015 Dec 29.
PubMed 26743833Sekii S, Tsujino K, Kosaka K, Yamaguchi S, Kubota H, Matsumoto Y, Ota Y, Sasaki R, Soejima T. Inversely designed, 3D-printed personalized template-guided interstitial brachytherapy for vaginal tumors. J Contemp Brachytherapy. 2018 Oct;10(5):470-477. doi: 10.5114/jcb.2018.78832. Epub 2018 Oct 9.
PubMed 30479625Harris BD, Nilsson S, Poole CM. A feasibility study for using ABS plastic and a low-cost 3D printer for patient-specific brachytherapy mould design. Australas Phys Eng Sci Med. 2015 Sep;38(3):399-412. doi: 10.1007/s13246-015-0356-3. Epub 2015 Jun 25.
PubMed 26108891Han K, Milosevic M, Fyles A, Pintilie M, Viswanathan AN. Trends in the utilization of brachytherapy in cervical cancer in the United States. Int J Radiat Oncol Biol Phys. 2013 Sep 1;87(1):111-9. doi: 10.1016/j.ijrobp.2013.05.033. Epub 2013 Jul 9.
PubMed 23849695
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study of Brachytherapy in Gynecological Cancers
- ClinicalTrials.gov ID
- NCT05242861
- Acronym / sponsor ID
- RetroBT / BTOG 2201
- Conditions
- Brachytherapy, Uterine Cervical Neoplasms, Uterine Neoplasms, Vulvar Cancer, Vaginal Cancer, Ovarian Neoplasms
- Keywords
- Brachytherapy, Cervical Cancer, Endometrial Cancer, Vaginal Cancer, Vulvar Cancer, Image Guided, 3D Print
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 20 Feb 2022 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Feb 2022 (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.
Brachytherapy for gynecological cancers will be studied retrospectively.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cervix radical BT | – | Radiation: Brachytherapy |
| Cervix adjuvant BT | – | Radiation: Brachytherapy |
| Cervix palliative BT | – | Radiation: Brachytherapy |
| Uterus BT | – | Radiation: Brachytherapy |
| Other GO cancer BT | – | Radiation: Brachytherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 18 to 80 years old female who diagnosed as gynecological cancer and underwent brachytherapy will be enrolled in this study.
Key inclusion criteria (3 listed)
- 18 - 80 female
- Underwent brachytherapy
- With gynecological cancer
Key exclusion criteria (1 listed)
- Refusal to enter this 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 |
|---|---|---|
| BrachytherapyApplicator, dose, schedule, technology, image, 3D print, efficacy, toxicity of brachytherapy | Radiation | Cervix adjuvant BT, Cervix palliative BT, Cervix radical BT, Other GO cancer BT, Uterus BT |
Primary outcome
Overall survival rate
Time frame: 5-year
the percentage of participants in the group who survives
2 secondary outcomes
Progression-free survival rate
Time frame: 5-year
Side effects
Time frame: 5-year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
- Background: PubMed 27134181Sturdza A, Potter R, Fokdal LU, Haie-Meder C, Tan LT, Mazeron R, Petric P, Segedin B, Jurgenliemk-Schulz IM, Nomden C, Gillham C, McArdle O, Van Limbergen E, Janssen H, Hoskin P, Lowe G, Tharavichitkul E, Villafranca E, Mahantshetty U, Georg P, Kirchheiner K, Kirisits C, Tanderup K, Lindegaard JC. Image guided brachytherapy in locally advanced cervical cancer: Improved pelvic control and survival in RetroEMBRACE, a multicenter cohort study. Radiother Oncol. 2016 Sep;120(3):428-433. doi: 10.1016/j.radonc.2016.03.011. Epub 2016 Apr 29.
- Background: PubMed 26743833Lindegaard JC, Madsen ML, Traberg A, Meisner B, Nielsen SK, Tanderup K, Spejlborg H, Fokdal LU, Norrevang O. Individualised 3D printed vaginal template for MRI guided brachytherapy in locally advanced cervical cancer. Radiother Oncol. 2016 Jan;118(1):173-5. doi: 10.1016/j.radonc.2015.12.012. Epub 2015 Dec 29.
- Background: PubMed 30479625Sekii S, Tsujino K, Kosaka K, Yamaguchi S, Kubota H, Matsumoto Y, Ota Y, Sasaki R, Soejima T. Inversely designed, 3D-printed personalized template-guided interstitial brachytherapy for vaginal tumors. J Contemp Brachytherapy. 2018 Oct;10(5):470-477. doi: 10.5114/jcb.2018.78832. Epub 2018 Oct 9.
- Background: PubMed 26108891Harris BD, Nilsson S, Poole CM. A feasibility study for using ABS plastic and a low-cost 3D printer for patient-specific brachytherapy mould design. Australas Phys Eng Sci Med. 2015 Sep;38(3):399-412. doi: 10.1007/s13246-015-0356-3. Epub 2015 Jun 25.
- Results publication: PubMed 23849695Han K, Milosevic M, Fyles A, Pintilie M, Viswanathan AN. Trends in the utilization of brachytherapy in cervical cancer in the United States. Int J Radiat Oncol Biol Phys. 2013 Sep 1;87(1):111-9. doi: 10.1016/j.ijrobp.2013.05.033. Epub 2013 Jul 9.
Related trials for Brachytherapy
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
Not yet recruiting
Characterizing Tumor Hypoxia With BOLD-MRI to Predict Y-90 Treatment Response
Hepatocellular Carcinoma, Liver Cancer
Active, not recruitingPhase 2
A Study of Shorter Course Hormone Therapy and Radiation for High-risk Prostate Cancer
Prostate Cancer
Recruiting
Photodynamic Therapy Combined With a Self-expandable Radioactive Particle-loaded Biliary Stent for Unresectable Extrahepatic Cholangiocarcinoma
Extrahepatic Cholangiocarcinoma
Recruiting
CT- Versus MRI-Based Planning for High-Dose-Rate Prostate Brachytherapy for Prostate Cancer
Prostate Carcinoma, Stage I Prostate Cancer AJCC v8
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.
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 Uterine Cervical Neoplasms, run by Zhejiang Cancer 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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 16 Feb 2022. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival rate (time frame: 5-year). 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 NCT05242861, which also lists 5 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 16 Feb 2022.