Image-guided Brachytherapy for Vaginal Cancer (EMBRAVE)

Official title

EMBRAVE: IntErnational Observational Study on Primary Chemoradiotherapy and iMage-based Adaptive BRAchytherapy for Vaginal cancEr

Overview

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.

Interventions

• Other Observational study (Non-interventional study)
  This is an observational study.

Primary outcome measures

• Local failure [Time frame: 2 and 5 years of follow-up]
• Late physician-assessed morbidity and patient reported outcomes [Time frame: 2 and 5 years of follow-up]
• Acute physician-assessed morbidity and patient reported outcomes [Time frame: End of Treatment]

Secondary outcome measures (1)

• Other oncological outcomes [Time frame: 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Netherlands · 1 center

• Erasmus MC — Rotterdam

Identifiers

NCT: NCT06514235 · MEC-2021-0820 · PaNaMa ID 6517

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗