MAASTRO HDR rectal applicator registry
Official title: Prospective Data Collection Initiative on MAASTRO HDR Rectal Applicator Treatments - a Prospective Observational Cohort Study.
Run by Maastricht Radiation Oncology · NCT07501845 · Data updated 2026-11-12
This registry collects data from adults with rectal cancer treated with the MAASTRO high-dose-rate (HDR) rectal applicator to see if different dose patterns relate to better tumor responses.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 999 (estimated) |
| Sponsor | Maastricht Radiation Oncology Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Maastricht) |
| Status | Recruiting |
| Started | March 23, 2026 |
| Main results expected | April 1, 2034 |
| Study ends | December 31, 2034 |
| Registry record updated | October 9, 2026 |
| Trial ID | NCT07501845 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with histologically proven or strongly suspected rectal cancer who are treated with the MAASTRO HDR rectal applicator and provide informed consent are eligible.
✕Probably not a fit
Patients not treated with the MAASTRO applicator, those unable to give informed consent, or those requiring immediate surgery are unlikely to benefit from this registry's findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational registry gathers longitudinal clinical and dosimetric data from patients treated with the MAASTRO HDR rectal applicator at Maastro, aiming to clarify dose–response relationships for rectal boosting. The applicator was designed to deliver a dose profile similar to contact X-ray radiotherapy while using HDR brachytherapy technology and has CE certification and initial clinical feasibility data. Collected information will include treatment parameters, tumor response (including complete response rates), and follow-up outcomes to inform patient selection and future protocols. Participation requires informed consent and includes adults with histologically proven or strongly suspected rectal cancer treated with the applicator.
Why it matters
Potential benefit: If successful, the registry could help tailor rectal radiation boosts to increase complete response rates and allow more patients to avoid surgery and its complications.
How similar studies have gone: Contact X-ray radiotherapy has shown higher complete response rates than EBRT boosts, and a recent clinical trial demonstrated the MAASTRO applicator is clinically feasible, so the approach has some promising prior support though broader outcome data remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years. * Histological proof of rectal cancer, or a strong suspicion after imaging. * Treatment with MAASTRO HDR rectal applicator * Informed consent for longitudinal observational data collection. Exclusion Criteria: * Mentally incompetent patients.
Where it's running
-
Maastro
Maastricht, Netherlands Recruiting
Study contacts
- Principal investigator: Maaike Berbée, MD, PhD — Maastro
- Study coordinator: Ann Claessens
- Email: ann.claessens@maastro.nl
- Phone: +31 88 44 55 600
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.