High dose radiotherapy boost for gynecological cancers when brachytherapy isn't possible

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 evaluate the effectiveness and side effects of a high dose daily adapted stereotactic body radiotherapy (SBRT) boost using MRLinac in patients with gynecological cancers who cannot receive brachytherapy. The study will assess how many patients achieve local control of their tumors and the side effects associated with this treatment. Participants will complete questionnaires regarding their experiences, and their clinical data may be utilized for research purposes. The MRLinac technology allows for better visualization and adaptation of treatment plans based on individual patient anatomy and tumor changes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with newly biopsy proven advanced stage gynecological cancers (excluding ovarian cancers) and endometrium in whom definitive (chemo)radiotherapy with curative intent is planned are qualified for the study, as well as, patients with recurrent gynecological cancers (excluding ovarian cancers) for which no prior (chemo)radiation was performed for which (chemo)radiotherapy with curative intent is planned.
* Patients with para-aortic metastatic nodes (stage IVB) to the level of L2 are also eligible but patients with further dissemination are not.
* Staging according to FIGO (2018, https://doi.org/10.1002/ijgo.12611) and TNM (version 9, 2021, https://doi.org/10.3322/caac.21663) staging.
* Patients who gave informed consent to take part in the MOMENTUM study (NCT04075305) to use their clinical data for publication and share their data with other (European) sites.

Exclusion Criteria:

* Hard contra-indication for MRI scanning

Where it's running

• Odense University Hospital
  Odense, Denmark Recruiting
• UMC Utrecht
  Utrecht, Netherlands Recruiting

Study contacts

• Study coordinator: van Lier, PhD
• Email: a.l.h.m.w.vanlier@umcutrecht.nl
• Phone: +31 88 755 8800

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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.