Image-guided Brachytherapy for Vaginal Cancer (EMBRAVE)

Launched by ERASMUS MEDICAL CENTER · Jul 16, 2024

Keywords

ClinConnect Summary

The EMBRAVE clinical trial is studying a treatment approach for women with vaginal cancer, aiming to improve their chances of recovery. This trial looks at using a specific kind of radiation therapy called image-guided adaptive brachytherapy (IGABT), along with other treatments like chemotherapy, to help patients who are being treated with the goal of curing their cancer. The researchers want to gather information to create helpful guidelines for future treatments and to understand how different factors might affect recovery and quality of life for patients.

To participate in this study, women must have been diagnosed with certain types of vaginal cancer and be willing to receive treatment with IGABT. Eligible participants should be in the early to moderate stages of cancer and not have any other significant health issues or previous treatments that could affect the study results. If you join the trial, you will receive treatment and be monitored over the next few years to see how well it works and to check for any side effects. This study is currently looking for at least 300 women to enroll, and it offers a chance to contribute to important research that could improve care for future patients with vaginal cancer.

Gender

FEMALE

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