NCT05242861

Brief Summary

Brachytherapy for gynecological cancers will be studied retrospectively.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Feb 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Feb 2022Dec 2027

First Submitted

Initial submission to the registry

February 6, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 16, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

February 20, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

February 16, 2022

Status Verified

February 1, 2022

Enrollment Period

2.9 years

First QC Date

February 6, 2022

Last Update Submit

February 6, 2022

Conditions

BrachytherapyUterine Cervical NeoplasmsUterine NeoplasmsVulvar CancerVaginal CancerOvarian NeoplasmsGynecologic Neoplasm

Keywords

BrachytherapyCervical CancerEndometrial CancerVaginal CancerVulvar CancerImage Guided3D Print

Outcome Measures

Primary Outcomes (1)

  • Overall survival rate

    the percentage of participants in the group who survives

    5-year

Secondary Outcomes (2)

  • Progression-free survival rate

    5-year

  • Side effects

    5-year

Study Arms (5)

Cervix radical BT

Radiation: Brachytherapy

Cervix adjuvant BT

Radiation: Brachytherapy

Cervix palliative BT

Radiation: Brachytherapy

Uterus BT

Radiation: Brachytherapy

Other GO cancer BT

Radiation: Brachytherapy

Interventions

BrachytherapyRADIATION

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

Cervix adjuvant BTCervix palliative BTCervix radical BTOther GO cancer BTUterus BT

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

18 to 80 years old female who diagnosed as gynecological cancer and underwent brachytherapy will be enrolled in this study.

You may qualify if:

  • female
  • Underwent brachytherapy
  • With gynecological cancer

You may not qualify if:

  • Refusal to enter this trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

Related Publications (5)

  • 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.

    PMID: 27134181BACKGROUND

  • 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.

    PMID: 26743833BACKGROUND

  • 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.

    PMID: 30479625BACKGROUND

  • 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.

    PMID: 26108891BACKGROUND

  • 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.

    PMID: 23849695RESULT

MeSH Terms

Conditions

Uterine Cervical NeoplasmsUterine NeoplasmsVulvar NeoplasmsVaginal NeoplasmsOvarian NeoplasmsGenital Neoplasms, FemaleEndometrial Neoplasms

Interventions

Brachytherapy

Condition Hierarchy (Ancestors)

Urogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesVulvar DiseasesVaginal DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeutics

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2022

First Posted

February 16, 2022

Study Start

February 20, 2022

Primary Completion

December 31, 2024

Study Completion (Estimated)

December 31, 2027

Last Updated

February 16, 2022

Record last verified: 2022-02

Locations

CN(1)