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Image-guided Brachytherapy for Vaginal Cancer (EMBRAVE)

NCT06514235RecruitingOBSERVATIONAL

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.

Key Facts

Lead Sponsor

Erasmus Medical Center

Enrollment

300

Start Date

2022-11-28

Completion Date

2033-11-30

Study Type

OBSERVATIONAL

Official Title

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

Interventions

Observational study (Non-interventional study)

Conditions

Vaginal Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

Local failure

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

Time frame: 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).

Time frame: 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).

Time frame: End of Treatment

Secondary Outcomes

Other oncological outcomes

Regional failure, distant metastasis, disease free survival, disease-specific survival, overall survival.

Time frame: 2 and 5 years of follow-up

Locations

Erasmus MC, Rotterdam, Netherlands

Linked Diseases

Vaginal Neoplasms

Vaginal Neoplasms — a type of gynecological cancer.