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
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.
- 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