NCT07501845

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
999

participants targeted

Target at P75+ for all trials

Timeline
102mo left

Started Mar 2026

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Mar 2026Dec 2034

First Submitted

Initial submission to the registry

March 12, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

March 23, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 30, 2026

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2034

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2034

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

8 years

First QC Date

March 12, 2026

Last Update Submit

April 8, 2026

Conditions

Rectal Cancer

Keywords

rectal cancerHDR Brachy

Outcome Measures

Primary Outcomes (9)

  • 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

Secondary Outcomes (3)

  • Health status

    From enrollment until 5 years after treatment

  • Long-term rectal functional outcome

    From enrollment until 5 years after treatment

  • Quality of life questionnaires

    From enrollment until 5 years after treatment

Study Arms (1)

Patients being treated with the MAASTRO HDR rectal applicator

Treatment with the MAASTRO HDR rectal applicator

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients being treated with the MAASTRO HDR rectal applicator

You may qualify if:

  • 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.

You may not qualify if:

  • Mentally incompetent patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastro

Maastricht, Netherlands

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Maaike Berbée, MD, PhD

    Maastro

    PRINCIPAL INVESTIGATOR

  • Britt Hupkens, MD, PhD

    Maastro

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ann Claessens

CONTACT

+31 88 44 55 600ann.claessens@maastro.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2026

First Posted

March 30, 2026

Study Start

March 23, 2026

Primary Completion (Estimated)

April 1, 2034

Study Completion (Estimated)

December 31, 2034

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations

NL(1)