Image-guided Brachytherapy for Vaginal Cancer (EMBRAVE)

NCT06514235 | Recruiting

• 2 other identifiers: MEC-2021-0820PaNaMa ID 6517
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginal Neoplasms

Outcome Measures

Primary Outcomes (3)

• Local failure

  A new, recurrent or progressive residual tumor within the external beam low-risk clinical target volume (CTV-TLR).

  2 and 5 years of follow-up

• Late physician-assessed morbidity and patient reported outcomes

  Physician-assessed (CTCAE v.5) and Patient Reported Outcome (EORTC C30, selected items of CX24, EN24 and VU34).

  2 and 5 years of follow-up

• Acute physician-assessed morbidity and patient reported outcomes

  Physician-assessed (CTCAE v.5) and Patient Reported Outcome (EORTC C30, selected items of CX24, EN24 and VU34).

  End of Treatment

Secondary Outcomes (1)

• Other oncological outcomes

  2 and 5 years of follow-up

Study Arms (1)

Primary vaginal cancer and Vaginal recurrence from any gynaecological cancer

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.

Other: Observational study (Non-interventional study)

Interventions

Observational study (Non-interventional study) OTHER

This is an observational study.

Primary vaginal cancer and Vaginal recurrence from any gynaecological cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with primary vaginal cancer stage I-IVA or vaginal recurrence from any gynaecologial cancer who are treated with curative intent by primary radio(chemo)therapy and MRI based image-guided adaptive brachytherapy.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Aarhus University Hospital: collaborator
• Amsterdam University Medical Center: collaborator
• Gustave Roussy, Cancer Campus, Grand Paris: collaborator
• Pitié-Salpêtrière Hospital: collaborator
• Leiden University Medical Center: collaborator
• Medical University of Vienna: collaborator

Study Sites (1)

Erasmus MC

Rotterdam, South Holland, 3015 CD, Netherlands

RECRUITING

MeSH Terms

Conditions

Vaginal Neoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Remi A. Nout, PhD

CONTACT

+31107041366; r.nout@erasmusmc.nl

René M. Vernhout, MSc

CONTACT

+31107041341; r.vernhout@erasmusmc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: July 23, 2024
• Study Start: November 28, 2022
• Primary Completion (Estimated): November 30, 2033
• Study Completion (Estimated): November 30, 2033
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

NL (1)