DETECT: DEfining the Target volume for Endoluminal radiation boosting in patients with reCTal cancer

DETECT: DEfining the Target volume for Endoluminal radiation boosting in patients with reCTal cancer - DETECT

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52208

Enrollment

Registered

2021-05-19

Start date

2023-11-20

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

rectal cancer rectal carcinoma

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - >=18 years of age and capable of giving informed consent. - ycT1-3N0-1 residual histology confirmed rectal adenocarcinoma after neoadjuvant  radiotherapy or long-course chemoradiotherapy for which patients will undergo  TME/PME surgery. - Minimal interval between end of neoadjuvant chemoradiotherapy or  radiotherapy: 6 weeks.

Exclusion criteria

Exclusion criteria: - Patient has received brachytherapy as part of neoadjuvant treatment. - <18 years of age or incapable of giving informed consent. - Patient has not been treated with neoadjuvant radiotherapy or long-course  chemoradiotherapy. - Patient will not undergo TME/PME surgery for a ycT1-3N0-1 residual histology  confirmed rectal adenocarcinoma. - Interval between end of neoadjuvant therapy and surgery is <6 weeks.

Design outcomes

Primary

Measure	Time frame
Maximum distance of microscopic tumor spread per patient in all directions: The maximum distance of microscopic tumor spread in all directions from the macroscopic remnant in the specimen will be measured per patient in millimeters using a standardized protocol by the pathology department.	—

Secondary

Measure	Time frame
Main secondary parameters/endpoints - Maximum distance of microscopic tumor spread per patient in all directions as seen by eye and/or on imaging (ultrasound, MRI): A tissue deformation factor/model and the location of the microscopic tumor spread in relation to the macroscopic remnant determined during pathological analysis, will be used to determine the maximum distance of microscopic tumor spread as seen by eye and/or on imaging (US, MRI) per patient in all directions in millimeters. - Treatment margin relative to the macroscopic tumor to cover 90% and 95% of MTS: 90% and 95% of the maximum distance of MTS in all directions in millimeters including 95% confidence intervals, both reported including and excluding ypT0-1 patients. Reported both by eye and on imaging, for which i.a. the tissue deformation model will be used.	—

Measure

Time frame

Main secondary parameters/endpoints - Maximum distance of microscopic tumor spread per patient in all directions as seen by eye and/or on imaging (ultrasound, MRI): A tissue deformation factor/model and the location of the microscopic tumor spread in relation to the macroscopic remnant determined during pathological analysis, will be used to determine the maximum distance of microscopic tumor spread as seen by eye and/or on imaging (US, MRI) per patient in all directions in millimeters. - Treatment margin relative to the macroscopic tumor to cover 90% and 95% of MTS: 90% and 95% of the maximum distance of MTS in all directions in millimeters including 95% confidence intervals, both reported including and excluding ypT0-1 patients. Reported both by eye and on imaging, for which i.a. the tissue deformation model will be used.

—

Countries

Netherlands

Contacts

Public ContactM Berbée

Maastro

groepCTO@maastro.nl088-4455600

Outcome results