DETECT: Target Volume for Rectal Endoluminal Radiation Boosting

Recruiting now

Conditions studied: Rectal Cancer

In brief

The aim of the study is to provide prospective data regarding microscopic tumor spread in all directions from the macroscopic tumor in pathology specimens, as seen by eye, and on imaging to define the target volume for endoluminal radiation boosting in rectal cancer patients.

Key facts

Study ID

NCT04927897

Run by

Maastricht Radiation Oncology

People needed

50

Starts

2022-08-16

Expected to finish

2027-12-01

Last updated by the study team

2025-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥18 years of age and capable of giving informed consent.
• ycT1-3N0(*) residual(**) histology confirmed rectal adenocarcinoma after neoadjuvant radiotherapy or long-course chemoradiotherapy for which patients will undergo TME surgery.
• Minimal interval between end of neoadjuvant chemoradiotherapy or radiotherapy: 6 weeks.
• (*)= as determined by clinical assessment (digital rectal examination, endoscopy with or without biopsy) and/or MRI. Biopsy/histology around the time of diagnosis is adequate; no biopsy/histology is needed after neoadjuvant therapy.
• (**)= including tumor regrowths/local recurrence after an initial clinical complete response and a "watch and wait" approach. These patients will also be included after the local recurrence has been determined using endoscopy and/or MRI.

You may not qualify if…

• 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 surgery for a ycT1-3N0 residual histology confirmed rectal adenocarcinoma.
• Interval between end of neoadjuvant therapy and surgery is <6 weeks.

Where it is running

• Maastro — Maastricht, Limburg, Netherlands (enrolling)
• Maastricht University Medical Center — Maastricht, Limburg, Netherlands (enrolling)
• Catharina Hospital — Eindhoven, North Brabant, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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