Registry Maastro Applicator
ConditionRectal Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMaastricht Radiation Oncology
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Mentally incompetent patients.
Trial population
Patients being treated with the MAASTRO HDR rectal applicator
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
999 Participants
are grouped into 1 trial groupGroup A: Patients being treated with the MAASTRO HDR rectal applicator
Trial outcomes
Primary outcomes
1
Efficacy of Maastro applicator endoluminal HDR contact brachytherapy boosting in functional organ sparing of the rectum.
Number of patients with clinical complete respons. Number of patients with treatment related adverse events as assessed by CTCAE v 4.0
Time frame
From enrollment to the end of FU at 10 years2
Percentage of planned interventional Maastro procedures that could be conducted successfully from a procedural point of view.
Percentage of planned interventional Maastro procedures that could be conducted successfully from a procedural point of view.
Time frame
During treatment3
Duration of the application procedure.
Duration of the application procedure.
Time frame
During treatment4
Clinical complete response rate up to 5 years after treatment.
Clinical complete response rate up to 5 years after treatment.
Time frame
From end of treatment until 5 years after treatmentSecondary outcomes
1
Health status
Separate informed consent will be asked to measure the health status and quality of life by QLQ-C30 ( EORTC Quality of Life Questionaires, Core 30) , QLQ-CR29 ( EORTC Quality of Life Questionaires ColoRectal 29 and EQ-5D ( EuroQoL-5D)
Time frame
From enrollment until 5 years after treatment2
Long-term rectal functional outcome
Separate informed consent will be asked to measure the Long-term rectal functional outcome by LARS score (Low Anterior Resection Syndrome - scale 0-42)
Time frame
From enrollment until 5 years after treatment3
Quality of life questionnaires
Separate informed consent will be asked to measure the quality of life by QLQ-C30 ( EORTC Quality of Life Questionaires, Core 30).
Time frame
From enrollment until 5 years after treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov