Image-guided treatment for vaginal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to enhance clinical outcomes for patients with vaginal cancer undergoing curative treatment with primary radio(chemo)therapy and image-guided adaptive brachytherapy (IGABT). It will develop evidence-based recommendations and identify prognostic factors related to oncological outcomes, morbidity, and quality of life. The study plans to enroll at least 300 patients and will evaluate oncological events at 2 and 5 years, along with assessing morbidity at multiple follow-up points.

Why it matters

Who can join: the full rules

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

Where it's running

• Erasmus MC
  Rotterdam, South Holland, Netherlands Recruiting

Study contacts

• Study coordinator: Remi A. Nout, PhD
• Email: r.nout@erasmusmc.nl
• Phone: +31107041366

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Becotatug Vedotin plus Zimberelimab in recurrent/metastatic cervical, vulvar, and vaginal cancers

  This study tests a targeted cancer drug linked to a toxin with a PD-1 blocker in women with recurrent or metastatic cervical, vulvar, or vaginal cancers who have already tried standard therapies.

  Recruiting Phase 2 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Hubei · NCT07424664

• SYMmetric Valve expansion to reduce hypoattenuated leaflet thickening after balloon-expandable TAVI

  This trial tests whether the Double-TAP post-dilatation strategy can reduce HALT and improve valve function in patients 70 or older undergoing balloon-expandable TAVI.

  Recruiting Erasmus Medical Center · Düsseldorf and 4 other locations · NCT07872020

• External warming to help septic patients without fever

  We’re testing whether warming the body externally can help people with sepsis who don’t have a fever.

  Recruiting Erasmus Medical Center · Rotterdam, South Holland · NCT07831057

• Personalized AI Education Avatar for cancer treatment information

  A digital avatar using AI-delivered educational videos helps adults starting new cancer treatments learn about their plan and side effects, with patient-friendly guidance and nurse support as needed.

  Recruiting Erasmus Medical Center · Rotterdam · NCT07715981

• Turbine-based CO2 Insufflator in Pediatric Laparoscopy

  A new turbine-powered CO2 insufflator is being tested in children to see if it can maintain steadier abdominal pressures during laparoscopic surgery.

  Recruiting Erasmus Medical Center · Rotterdam, South Holland · NCT07715968

• Guideline Adherence in HFrEF: See If Mirror Information Helps Doctors and Patients Follow GDMT

  This study tests whether showing doctors, or both doctors and patients, mirror information about how well guideline-directed medical therapy is being used in heart failure with reduced ejection fraction.

  Recruiting Erasmus Medical Center · Rotterdam · NCT07702760

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.