Image-guided treatment for vaginal cancer
EMBRAVE: IntErnational Observational Study on Primary Chemoradiotherapy and iMage-based Adaptive BRAchytherapy for Vaginal cancEr
This study is testing if using image-guided treatment can improve the results and quality of life for patients with vaginal cancer receiving radiation therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Erasmus Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rotterdam, South Holland) |
| Trial ID | NCT06514235 on ClinicalTrials.gov |
What this trial studies
This observational study aims to enhance clinical outcomes for patients with vaginal cancer undergoing curative treatment with primary radio(chemo)therapy and image-guided adaptive brachytherapy (IGABT). It will develop evidence-based recommendations and identify prognostic factors related to oncological outcomes, morbidity, and quality of life. The study plans to enroll at least 300 patients and will evaluate oncological events at 2 and 5 years, along with assessing morbidity at multiple follow-up points.
Who should consider this trial
Good fit: Ideal candidates include individuals with histologically proven primary vaginal cancer or carcinoma in situ, specifically those with squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.
Not a fit: Patients with non-epithelial vaginal cancers or those not meeting the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols and better outcomes for patients with vaginal cancer.
How similar studies have performed: While this approach is observational, similar studies in the field of brachytherapy have shown promising results in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: o Histologically proven primary vaginal cancer, vaginal carcinoma in situ (VAIN) or vaginal recurrence, per WHO classification. Histological proven stage I-IVA primary vaginal cancer: squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the vagina, other epithelial carcinoma's and carcinoma in situ * Histological proven vaginal recurrence from any gynaecological cancer for whom curative treatment is envisioned that includes image guided adaptive brachytherapy according to the target concept. * Para-aortic lymph node metastasis below L1-L2 interspace are allowed * Macroscopic visible tumour present on MRI and/or gynaecological examination at diagnosis. * Planned IGABT treatment with MRI-guided adaptive brachytherapy (at least the 1st fraction contouring and planning on MRI; CT for later fractions is allowed): * External beam radio(chemo)therapy followed by IGABT * IGABT alone for stage I \<2cm or carcinoma in situ * Treatment with curative intent * Written informed consent Exclusion Criteria: * Primary 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 without brachytherapy to boost the primary disease * Primary vaginal cancer: treatment by primary surgery or debulking surgery * Vaginal recurrences: treatment by primary surgery or debulking surgery * Treatment with neo-adjuvant chemotherapy followed by surgery * Treatment with radiotherapy followed by surgery * Previous pelvic or abdominal radiotherapy * Pregnancy
Where this trial is running
Rotterdam, South Holland
- Erasmus MC — Rotterdam, South Holland, Netherlands (Recruiting)
Study contacts
- Study coordinator: Remi A. Nout, PhD
- Email: r.nout@erasmusmc.nl
- Phone: +31107041366
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.