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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05242861
Other study ID # BTOG 2201
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 20, 2022
Est. completion date December 31, 2027

Study information

Verified date February 2022
Source Zhejiang Cancer Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Brachytherapy for gynecological cancers will be studied retrospectively.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date December 31, 2027
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - 18 - 80 female - Underwent brachytherapy - With gynecological cancer Exclusion Criteria: - Refusal to enter this trial

Study Design


Intervention

Radiation:
Brachytherapy
Applicator, dose, schedule, technology, image, 3D print, efficacy, toxicity of brachytherapy

Locations

Country Name City State
China Zhejiang Cancer Hospital Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Overall survival rate the percentage of participants in the group who survives 5-year
Secondary Progression-free survival rate the percentage of participants in the group whose disease is likely to remain stable 5-year
Secondary Side effects side effects associated with treatment 5-year
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