Clinical trial · Observational
Registry Maastro Applicator
Prospective Data Collection Initiative on MAASTRO HDR Rectal Applicator Treatments - a Prospective Observational Cohort Study.
NCT07501845CI-TRIAL-00107807recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This registry will collect data from all patients treated with the MAASTRO HDR applicator. The goal is to deepen knowledge about dose-response relationships in rectal cancer boosting, which is essential for improving future treatment approaches and patient selection.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Patients being treated with the MAASTRO HDR rectal applicator
- description
- Treatment with the MAASTRO HDR rectal applicator
Primary outcomes (9)
- measure
- Efficacy of Maastro applicator endoluminal HDR contact brachytherapy boosting in functional organ sparing of the rectum.
- timeFrame
- From enrollment to the end of FU at 10 years
- description
- Number of patients with clinical complete respons. Number of patients with treatment related adverse events as assessed by CTCAE v 4.0
- measure
- Percentage of planned interventional Maastro procedures that could be conducted successfully from a procedural point of view.
- timeFrame
- During treatment
- description
- Percentage of planned interventional Maastro procedures that could be conducted successfully from a procedural point of view.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.