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.
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
Study Type
OBSERVATIONAL
Enrollment
999
Maastro
Maastricht, Netherlands
RECRUITINGEfficacy 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 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.
Time frame: During treatment
Duration of the application procedure.
Duration of the application procedure.
Time frame: During treatment
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 treatment
Toxcity up to 3 year after treatment
Rectal and genitourinary toxicity scored according to CTCAE v. 5 up to 3 years after treatment
Time frame: 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
Time frame: from enrollment until 10 years after treatment
Salvage surgery
Salvage surgery rate after treatment.
Time frame: From end of treatment until 5 years after treatment
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Overall and disease specific survival rate
Overall and disease specific survival rate up to 10 year after treatment.
Time frame: from enrollment until 10 years after treatment
Discomfort/pain
Discomfort/pain during endorectal irradiation using NRS (Numeric Rating Scale 0-10) painscore
Time frame: From baseline up to 2 weeks after last fraction
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 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)
Time frame: 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).
Time frame: From enrollment until 5 years after treatment