MAASTRO HDR rectal applicator registry
Prospective Data Collection Initiative on MAASTRO HDR Rectal Applicator Treatments - a Prospective Observational Cohort Study.
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 |
|---|---|
| Enrollment | 999 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Maastricht Radiation Oncology Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Maastricht) |
| Trial ID | NCT07501845 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Maastricht
- 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
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.