- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05242861
Retrospective Study of Brachytherapy (RetroBT)
February 6, 2022 updated by: Zhejiang Cancer Hospital
A Retrospective Study of Brachytherapy in Gynecological Cancers
Brachytherapy for gynecological cancers will be studied retrospectively.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310022
- Recruiting
- Zhejiang Cancer Hospital
-
Principal Investigator:
- Xiang Zhang
-
Contact:
- Xiang Zhang
- Phone Number: 0086-571-88122048
- Email: zhangxiang@zjcc.org.cn
-
Sub-Investigator:
- Jianhong Chen
-
Sub-Investigator:
- Yeqiang Tu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
18 to 80 years old female who diagnosed as gynecological cancer and underwent brachytherapy will be enrolled in this study.
Description
Inclusion Criteria:
- 18 - 80 female
- Underwent brachytherapy
- With gynecological cancer
Exclusion Criteria:
- Refusal to enter this trial
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Cervix radical BT
|
Applicator, dose, schedule, technology, image, 3D print, efficacy, toxicity of brachytherapy
|
|
Cervix adjuvant BT
|
Applicator, dose, schedule, technology, image, 3D print, efficacy, toxicity of brachytherapy
|
|
Cervix palliative BT
|
Applicator, dose, schedule, technology, image, 3D print, efficacy, toxicity of brachytherapy
|
|
Uterus BT
|
Applicator, dose, schedule, technology, image, 3D print, efficacy, toxicity of brachytherapy
|
|
Other GO cancer BT
|
Applicator, dose, schedule, technology, image, 3D print, efficacy, toxicity of brachytherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall survival rate
Time Frame: 5-year
|
the percentage of participants in the group who survives
|
5-year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Progression-free survival rate
Time Frame: 5-year
|
the percentage of participants in the group whose disease is likely to remain stable
|
5-year
|
|
Side effects
Time Frame: 5-year
|
side effects associated with treatment
|
5-year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Lindegaard 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.
- Sekii 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.
- Harris 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.
- Han 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
February 20, 2022
Primary Completion (Anticipated)
December 31, 2024
Study Completion (Anticipated)
December 31, 2027
Study Registration Dates
First Submitted
February 6, 2022
First Submitted That Met QC Criteria
February 6, 2022
First Posted (Actual)
February 16, 2022
Study Record Updates
Last Update Posted (Actual)
February 16, 2022
Last Update Submitted That Met QC Criteria
February 6, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Cervical Diseases
- Uterine Diseases
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Vaginal Diseases
- Vulvar Diseases
- Neoplasms
- Uterine Cervical Neoplasms
- Ovarian Neoplasms
- Vulvar Neoplasms
- Genital Neoplasms, Female
- Vaginal Neoplasms
- Uterine Neoplasms
Other Study ID Numbers
- BTOG 2201
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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