Retrospective Study of Brachytherapy

Ovarian Neoplasms Clinical Trial

— RetroBT  

Official title:

A Retrospective Study of Brachytherapy in Gynecological Cancers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05242861
• Other study ID #: BTOG 2201
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Brachytherapy
• Genital Neoplasms, Female
• Gynecologic Neoplasm
• Neoplasms
• Ovarian Neoplasms
• Uterine Cervical Neoplasms
• Uterine Neoplasms
• Vaginal Cancer
• Vaginal Neoplasms
• Vulvar Cancer
• Vulvar Neoplasms

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