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Registry Maastro Applicator 999
Clinical Trial NCT07501845 is an observational study for Rectal Cancer and is currently not yet recruiting. Enrollment is planned to begin on March 15, 2026 and continue until the study accrues 999 participants. Led by Maastricht Radiation Oncology, this study is expected to complete by December 31, 2034. The latest data from ClinicalTrials.gov was last updated on March 30, 2026.
Brief Summary
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 watc...Show More
Official Title
Prospective Data Collection Initiative on MAASTRO HDR Rectal Applicator Treatments - a Prospective Observational Cohort Study.
Conditions
Rectal CancerOther Study IDs
- Registry Maastro Applicator
NCT ID Number
Start Date (Actual)
2026-03-15
Last Update Posted
2026-03-30
Completion Date (Estimated)
2034-12-31
Enrollment (Estimated)
999
Study Type
Observational
Status
Not yet recruiting
Keywords
rectal cancer
HDR Brachy
HDR Brachy
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Patients being treated with the MAASTRO HDR rectal applicator Treatment with the MAASTRO HDR rectal applicator | N/A |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 | 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. | Percentage of planned interventional Maastro procedures that could be conducted successfully from a procedural point of view. | During treatment |
Duration of the application procedure. | Duration of the application procedure. | During treatment |
Clinical complete response rate up to 5 years after treatment. | Clinical complete response rate up to 5 years after treatment. | From end of treatment until 5 years after treatment |
Toxcity up to 3 year after treatment | Rectal and genitourinary toxicity scored according to CTCAE v. 5 up to 3 years after treatment | From start treatment until 3 years after the end of treatment |
Disease status up to 10 years after treatment | Local and locolregional recurrence rate and metastatic rate up to 10 years after treatment | from enrollment until 10 years after treatment |
Salvage surgery | Salvage surgery rate after treatment. | From end of treatment until 5 years after treatment |
Overall and disease specific survival rate | Overall and disease specific survival rate up to 10 year after treatment. | from enrollment until 10 years after treatment |
Discomfort/pain | Discomfort/pain during endorectal irradiation using NRS (Numeric Rating Scale 0-10) painscore | From baseline up to 2 weeks after last fraction |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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) | From enrollment until 5 years after treatment |
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) | From enrollment until 5 years after treatment |
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). | From enrollment until 5 years after treatment |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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.
- Mentally incompetent patients.
Maastricht Radiation OncologyStudy Central Contact
Contact: Ann Claessens, +31 88 44 55 600, [email protected]
No location data.