High dose radiotherapy boost for gynecological cancers when brachytherapy isn't possible
MRLinac Boost for Gynecological Cancers if Brachytherapy is Not Feasible
This study tests if a high dose of a special type of radiation treatment can help control tumors in women with gynecological cancers who can't have brachytherapy, while also looking at any side effects they might experience.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | UMC Utrecht Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 2 sites (Odense and 1 other locations) |
| Trial ID | NCT05937958 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with advanced stage gynecological cancers (excluding ovarian and endometrial cancers) who are planned for definitive (chemo)radiotherapy.
Not a fit: Patients with hard contraindications for MRI scanning will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer and more effective treatment option for patients with gynecological cancers who are ineligible for brachytherapy.
How similar studies have performed: While the use of MRLinac for this purpose is relatively novel, similar approaches in radiotherapy have shown promise in improving treatment outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Odense and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.