RetroBT: Retrospective Study of Brachytherapy
Sponsor
Zhejiang Cancer Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05242861
Collaborator
(none)
300
1
70.3
4.3
Study Details
Study Description
Brief Summary
Brachytherapy for gynecological cancers will be studied retrospectively.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
300 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
A Retrospective Study of Brachytherapy in Gynecological Cancers
Anticipated Study Start Date
:
Feb 20, 2022
Anticipated Primary Completion Date
:
Dec 31, 2024
Anticipated Study Completion Date
:
Dec 31, 2027
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Cervix radical BT
|
Radiation: Brachytherapy
Applicator, dose, schedule, technology, image, 3D print, efficacy, toxicity of brachytherapy
|
| Cervix adjuvant BT
|
Radiation: Brachytherapy
Applicator, dose, schedule, technology, image, 3D print, efficacy, toxicity of brachytherapy
|
| Cervix palliative BT
|
Radiation: Brachytherapy
Applicator, dose, schedule, technology, image, 3D print, efficacy, toxicity of brachytherapy
|
| Uterus BT
|
Radiation: Brachytherapy
Applicator, dose, schedule, technology, image, 3D print, efficacy, toxicity of brachytherapy
|
| Other GO cancer BT
|
Radiation: Brachytherapy
Applicator, dose, schedule, technology, image, 3D print, efficacy, toxicity of brachytherapy
|
Outcome Measures
Primary Outcome Measures
- Overall survival rate [5-year]
the percentage of participants in the group who survives
Secondary Outcome Measures
- Progression-free survival rate [5-year]
the percentage of participants in the group whose disease is likely to remain stable
- Side effects [5-year]
side effects associated with treatment
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
18 - 80 female
-
Underwent brachytherapy
-
With gynecological cancer
Exclusion Criteria:
- Refusal to enter this trial
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zhejiang Cancer Hospital | Hangzhou | Zhejiang | China | 310022 |
Sponsors and Collaborators
- Zhejiang Cancer Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- Lindegaard JC, Madsen ML, Traberg A, Meisner B, Nielsen SK, Tanderup K, Spejlborg H, Fokdal LU, Nørrevang 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.
- Sturdza A, Pötter R, Fokdal LU, Haie-Meder C, Tan LT, Mazeron R, Petric P, Šegedin 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.
Responsible Party:
Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier:
NCT05242861
Other Study ID Numbers:
- BTOG 2201
First Posted:
Feb 16, 2022
Last Update Posted:
Feb 16, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Zhejiang Cancer Hospital
Additional relevant MeSH terms: