Ignite Creation Date:
2024-10-25 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06514235
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-04
Brief Title:
Image-guided Brachytherapy for Vaginal Cancer EMBRAVE
Sponsor:
None
Organization:
None
Study Overview
Official Title:
EMBRAVE IntErnational Observational Study on Primary Chemoradiotherapy and iMage-based Adaptive BRAchytherapy for Vaginal cancEr
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMBRAVE
Brief Summary:
The goal of this clinical study is to improve clinical outcomes of patients with vaginal cancer who are treated with curative intent by primary radiochemotherapy and image-guided adaptive brachytherapy IGABT
Being an observational prospective registration study wherein neither an experimental treatment is compared to the standard treatment nor groups of patients are compared
The specific aims are
to develop evidence-based recommendations for curative intent treatment with primary radiochemotherapy and IGABT
to identify prognostic parameters for oncological outcomes morbidity and quality of life
The study aims to enroll at least 300 patients Oncological events will be evaluated at 2 and 5 years of follow-up Acute and late morbidity events will be evaluated at end of treatment 2 and 5 years of follow-up
Being an observational prospective registration study wherein neither an experimental treatment is compared to the standard treatment nor groups of patients are compared
The specific aims are
to develop evidence-based recommendations for curative intent treatment with primary radiochemotherapy and IGABT
to identify prognostic parameters for oncological outcomes morbidity and quality of life
The study aims to enroll at least 300 patients Oncological events will be evaluated at 2 and 5 years of follow-up Acute and late morbidity events will be evaluated at end of treatment 2 and 5 years of follow-up
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None