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NCT Number: NCT07501845

Registry Maastro Applicator

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

    Number of patients with clinical complete respons. Number of patients with treatment related adverse events as assessed by CTCAE v 4.0

  2. Percentage of planned interventional Maastro procedures that could be conducted successfully from a procedural point of view.

    Time frame: During treatment

    Percentage of planned interventional Maastro procedures that could be conducted successfully from a procedural point of view.

  3. Duration of the application procedure.

    Time frame: During treatment

    Duration of the application procedure.

  4. Clinical complete response rate up to 5 years after treatment.

    Time frame: From end of treatment until 5 years after treatment

    Clinical complete response rate up to 5 years after treatment.

  5. Toxcity up to 3 year after treatment

    Time frame: From start treatment until 3 years after the end of treatment

    Rectal and genitourinary toxicity scored according to CTCAE v. 5 up to 3 years after treatment

  6. Disease status up to 10 years after treatment

    Time frame: from enrollment until 10 years after treatment

    Local and locolregional recurrence rate and metastatic rate up to 10 years after treatment

  7. Salvage surgery

    Time frame: From end of treatment until 5 years after treatment

    Salvage surgery rate after treatment.

  8. Overall and disease specific survival rate

    Time frame: from enrollment until 10 years after treatment

    Overall and disease specific survival rate up to 10 year after treatment.

  9. Discomfort/pain

    Time frame: From baseline up to 2 weeks after last fraction

    Discomfort/pain during endorectal irradiation using NRS (Numeric Rating Scale 0-10) painscore

Secondary outcomes

  1. Health status

    Time frame: From enrollment until 5 years after treatment

    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)

  2. Long-term rectal functional outcome

    Time frame: From enrollment until 5 years after treatment

    Separate informed consent will be asked to measure the Long-term rectal functional outcome by LARS score (Low Anterior Resection Syndrome - scale 0-42)

  3. Quality of life questionnaires

    Time frame: From enrollment until 5 years after treatment

    Separate informed consent will be asked to measure the quality of life by QLQ-C30 ( EORTC Quality of Life Questionaires, Core 30).

Study contacts

Contact information is provided by the study sponsor or research team.

Ann Claessens

CONTACT

[email protected]

+31 88 44 55 600

Sponsors and collaborators

Lead sponsor

Maastricht Radiation Oncology

Other

Registry information

Official study title

Prospective Data Collection Initiative on MAASTRO HDR Rectal Applicator Treatments - a Prospective Observational Cohort Study.

Important dates

Study start
2026
Primary completion
2034
Study completion
2034
First posted
Mar 30, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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