Defining target volume for radiation boosting in rectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to gather prospective data on the microscopic spread of rectal cancer tumors to better define the target volume for endoluminal radiation boosting. It involves a multicenter cohort of at least 50 patients with residual rectal adenocarcinoma after neoadjuvant treatment. Patients will undergo standard workup procedures, including flexible endoscopy and MRI, along with additional endorectal ultrasound and rigid rectoscopy. The study will analyze tumor spread in all directions and develop a tissue deformation model to translate findings back to in vivo imaging.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* ≥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.

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

Where it's running

• Maastro
  Maastricht, Limburg, Netherlands Recruiting
• Maastricht University Medical Center
  Maastricht, Limburg, Netherlands Recruiting
• Catharina Hospital
  Eindhoven, North Brabant, Netherlands Recruiting

Study contacts

• Principal investigator: Maaike Berbée, MD, PhD — Maastro
• Study coordinator: Maaike Berbée, MD, PhD
• Email: maaike.berbee@maastro.nl
• Phone: 0031884455600

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.