Image-guided Brachytherapy for Vaginal Cancer (EMBRAVE)
- Conditions
- Vaginal Neoplasms
- Interventions
- Other: Observational study (Non-interventional study)
- Registration Number
- NCT06514235
- Lead Sponsor
- Erasmus Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 300
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Primary vaginal cancer Observational study (Non-interventional study) Adult patients with vaginal cancer treated with curative intent by primary radio(chemo)therapy and MRI based image-guided adaptive brachytherapy according to the protocol target concept.
- Primary Outcome Measures
Name Time Method Local failure 2 and 5 years of follow-up A new, recurrent or progressive residual tumor within the external beam low-risk clinical target volume (CTV-TLR).
Acute physician-assessed morbidity and patient reported outcomes End of Treatment Physician-assessed (CTCAE v.5) and Patient Reported Outcome (EORTC C30, selected items of CX24, EN24 and VU34).
Late physician-assessed morbidity and patient reported outcomes 2 and 5 years of follow-up Physician-assessed (CTCAE v.5) and Patient Reported Outcome (EORTC C30, selected items of CX24, EN24 and VU34).
- Secondary Outcome Measures
Name Time Method Other oncological outcomes 2 and 5 years of follow-up Regional failure, distant metastasis, disease free survival, disease-specific survival, overall survival.
Trial Locations
- Locations (1)
Erasmus MC
🇳🇱Rotterdam, Zuid-Holland, Netherlands