Registry Maastro Applicator
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Rectal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective Data Collection Initiative on MAASTRO HDR Rectal Applicator Treatments - a Prospective Observational Cohort Study.
Overview
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.
Detailed description
Standard treatment for rectal cancer usually involves surgical removal of the tumor. Depending on the tumor's characteristics, patients may first receive neoadjuvant therapy such as radiotherapy, chemoradiotherapy, or total neoadjuvant treatment (TNT). These treatments aim to improve oncological outcomes and can lead to a complete response (CR) in about 10-40% of patients. When a CR occurs, patients may choose a watch-and-wait strategy, which avoids surgery and improves quality of life by preventing complications such as incontinence or the need for a stoma.
Increasing the radiation dose improves the chance of achieving a CR. Endoluminal boost techniques-high-dose-rate (HDR) brachytherapy and contact X-ray radiotherapy (CXRT)-allow a highly localized radiation boost. CXRT has shown higher CR rates than external beam radiotherapy (EBRT) boosts (81% vs. 60%). However, widespread use of endoluminal boosting is limited by the high cost of CXRT equipment and the less favorable dose distribution of HDR brachytherapy.
To overcome these limitations, MAASTRO, in collaboration with Varian Inc., developed a new HDR rectal brachytherapy applicator that delivers a dose profile similar to CXRT. The applicator has received CE certification and is now available for clinical use. A recent clinical trial confirmed that treatment with this applicator is clinically feasible. As a result, MAASTRO HDR treatment is now part of standard care.
To improve understanding of treatment outcomes and optimize future strategies, a prospective observational cohort study has been initiated.This project is designed to continuously include new patients and will provide an ongoing source for multiple future studies
Primary outcome measures
- Efficacy of Maastro applicator endoluminal HDR contact brachytherapy boosting in functional organ sparing of the rectum. [Time frame: From enrollment to the end of FU at 10 years]
- Percentage of planned interventional Maastro procedures that could be conducted successfully from a procedural point of view. [Time frame: During treatment]
- Duration of the application procedure. [Time frame: During treatment]
- Clinical complete response rate up to 5 years after treatment. [Time frame: From end of treatment until 5 years after treatment]
- Toxcity up to 3 year after treatment [Time frame: From start treatment until 3 years after the end of treatment]
- Disease status up to 10 years after treatment [Time frame: from enrollment until 10 years after treatment]
- Salvage surgery [Time frame: From end of treatment until 5 years after treatment]
- Overall and disease specific survival rate [Time frame: from enrollment until 10 years after treatment]
- Discomfort/pain [Time frame: From baseline up to 2 weeks after last fraction]
Secondary outcome measures (3)
- Health status [Time frame: From enrollment until 5 years after treatment]
- Long-term rectal functional outcome [Time frame: From enrollment until 5 years after treatment]
- Quality of life questionnaires [Time frame: From enrollment until 5 years after treatment]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 1 center
- Maastro — Maastricht
Identifiers
NCT: NCT07501845 · Registry Maastro Applicator