Status:
RECRUITING
Image-guided Brachytherapy for Vaginal Cancer (EMBRAVE)
Lead Sponsor:
Erasmus Medical Center
Collaborating Sponsors:
Aarhus University Hospital
Amsterdam University Medical Center
Conditions:
Vaginal Neoplasms
Eligibility:
FEMALE
18+ years
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 im...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 28 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 30 2033
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06514235
Start Date
November 28 2022
End Date
November 30 2033
Last Update
August 19 2025
Active Locations (1)
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1
Erasmus MC
Rotterdam, South Holland, Netherlands, 3015 CD