Clinical trial NCT06514235: Image-guided Brachytherapy for Vaginal Cancer (EMBRAVE)
Official title: EMBRAVE: IntErnational Observational Study on Primary Chemoradiotherapy and iMage-based Adaptive BRAchytherapy for Vaginal cancEr
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vaginal Neoplasms
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2024-07-23
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with primary vaginal cancer stage I-IVA who are treated with curative intent by primary radio(chemo)therapy and MRI based image-guided adaptive brachytherapy.

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 radio(chemo)therapy 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 radio(chemo)therapy 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.


Eligibility criteria: Inclusion Criteria:

* Histologically proven primary vaginal cancer or carcinoma in situ, per WHO classification
* Histological types: main cohort: squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the vagina; parallel cohort: other epithelial carcinomas and carcinoma in situ/vaginal intraepithelial neoplasia, as per WHO classification
* Primary vaginal cancer are treated following the protocol target concept.
* Primary vaginal cancer: Stage I-IVA; para-aortic lymph node metastasis below L1-L2 interspace are allowed
* Planned IGABT treatment with MRI-guided adaptive brachytherapy (at least the 1st fraction contouring and planning on MRI; CT for later fractions is allowed); main cohort: External beam radio(chemo)therapy followed by IGABT; parallel cohort IGABT alone
* IGABT alone for stage I \<2 cm or carcinoma in situ will be registered in a parallel cohort in this study
* Treatment with curative intent
* Written informed consent

Exclusion Criteria:

* Vaginal cancers with involvement of the ostium of the cervix or vulva (these should be classified as cervical cancer or vulvar cancer, respectively)
* Metastatic disease beyond para-aortic region L1-L2 interspace
* Sarcomas and melanomas.
* Treatment only by external beam radiotherapy
* Treatment by primary surgery or debulking surgery
* Treatment with neo-adjuvant radiotherapy and/or neo-adjuvant chemotherapy followed by surgery
* Treatment including neo-adjuvant or adjuvant chemotherapy
* Previous pelvic or abdominal radiotherapy
* Pregnancy

Primary outcomes:
measure: Local failure
timeFrame: 2 and 5 years of follow-up
measure: Late physician-assessed morbidity and patient reported outcomes
timeFrame: 2 and 5 years of follow-up
measure: Acute physician-assessed morbidity and patient reported outcomes
timeFrame: End of Treatment
Secondary outcomes:
measure: Other oncological outcomes
timeFrame: 2 and 5 years of follow-up
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
state: Zuid-Holland
Study officials:
References: