NCT06514235 Image-guided Brachytherapy for Vaginal Cancer (EMBRAVE)
| NCT ID | NCT06514235 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Erasmus Medical Center |
| Condition | Vaginal Neoplasms |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2022-11-28 |
| Primary Completion | 2033-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2022-11-28 with a primary completion date of 2033-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical study is to improve clinical outcomes of patients with vaginal cancer including vaginal recurrences 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: 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06514235 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Vaginal Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06514235 currently recruiting?
Yes, NCT06514235 is actively recruiting participants. Contact the research team at r.nout@erasmusmc.nl for enrollment information.
Where is the NCT06514235 trial being conducted?
This trial is being conducted at Rotterdam, Netherlands.
Who is sponsoring the NCT06514235 clinical trial?
NCT06514235 is sponsored by Erasmus Medical Center. The trial plans to enroll 300 participants.