DETECT: Target Volume for Rectal Endoluminal Radiation Boosting

NCT04927897 | Recruiting

• 1 other identifier: NL77886.068.21
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Rectal Cancer

Keywords

Rectal Cancer; Microscopic Tumor Spread; Target Volume Definition; Endoluminal Radiation Boosting

Outcome Measures

Primary Outcomes (1)

• Maximum distance of microscopic tumor spread per patient in all directions from the macroscopic tumor remnant in the pathology specimen

  The maximum distance of microscopic tumor spread in all directions from the macroscopic remnant in the specimen will be measured per patient in millimeters by the pathology department in the pathologic resection specimens.

  During post-resection pathological analysis (i.e. approximately 14 days post-resection)

Secondary Outcomes (8)

• Maximum distance of microscopic tumor spread per patient from the macroscopic tumor remnant in the pathology specimen, reported separately for MTS perpendicular to the bowel wall and for MTS parallel to the bowel wall

  During post-resection pathological analysis (i.e. approximately 14 days post-resection)

• Maximum distance of microscopic tumor spread per patient in all directions from the macroscopic tumor remnant in the pathology specimen excluding ypT0 patients

  During post-resection pathological analysis (i.e. approximately 14 days post-resection)

• Maximum distance of microscopic tumor spread per patient in all directions from the macroscopic tumor remnant in the pathology specimen only including patients with microscopic tumor spread

  During post-resection pathological analysis (i.e. approximately 14 days post-resection)

• Maximum distance of microscopic tumor spread per patient in all directions from the macroscopic tumor remnant in the pathology specimen only for patients with regrowths

  During post-resection pathological analysis (i.e. approximately 14 days post-resection)

• Tissue deformation factor/model to compensate for tissue deformation due to removal of the specimen from the body, formalin fixation and tissue processing at the pathology department

  The tissue deformation model will be created once all required data (e.g. MRI scans, rectoscopy images, endorectal ultrasound images) is available (approximately 14 days post-surgery for the final included patient).

Other Outcomes (2)

• Identification of potential risk factors for the presence and the extent of microscopic tumor spread not yet identified by our meta-analysis

  Most are determined during post-resection path. analysis (approx. 14 days post-resection). ycT stage is determined approx. 6-10 weeks post-neoadjuvant treatment (multidisciplinary team), in vivo imaging is done approx 6-8 weeks post-neoadjuvant treatment

• Analysis of (re)biopsy material

  Biopsy material is obtained at time of diagnosis.

Study Arms (1)

Observational

In addition to standard workup and treatment, patients will undergo pre-operatively, after induction of general anaesthesia, an endorectal ultrasound and rigid rectoscopy as study procedures if these are not part of standard workup yet.

Diagnostic Test: Ultrasound; Diagnostic Test: Rectoscopy; Other: Scan, e.g. CT (resection specimen)

Interventions

Ultrasound DIAGNOSTIC_TEST

3D endorectal ultrasound.

Observational

Rectoscopy DIAGNOSTIC_TEST

Rigid rectoscopy.

Observational

Scan, e.g. CT (resection specimen) OTHER

For some patients, images of the resection specimen (note: NOT of the patients) during the pathological process will be acquired.

Observational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with a limited (ycT1-3N0) residual tumor after neoadjuvant radiotherapy or long-course chemoradiotherapy for rectal adenocarcinoma.

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.

Sponsors & Collaborators

• Maastricht Radiation Oncology: lead
• Maastricht University Medical Center: collaborator
• Catharina Ziekenhuis Eindhoven: collaborator

Study Sites (3)

Maastro

Maastricht, Limburg, 6229 ET, Netherlands

RECRUITING

Maastricht University Medical Center

Maastricht, Limburg, 6229 HX, Netherlands

RECRUITING

Catharina Hospital

Eindhoven, North Brabant, 5623 EJ, Netherlands

RECRUITING

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Biospecimen

Retention: SAMPLES WITHOUT DNA

* The (re)biopsy material * (Part of) the material of the pathological rectal specimen after TME surgery Both are part of standard clinical care.

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Ultrasonography; Proctoscopy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Maaike Berbée, MD, PhD

  Maastro

  PRINCIPAL INVESTIGATOR

• Evert Van Limbergen, MD, PhD

  Maastro

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maaike Berbée, MD, PhD

CONTACT

0031884455600; maaike.berbee@maastro.nl

Evert Van Limbergen, MD, PhD

CONTACT

0031884455600; evert.vanlimbergen@maastro.nl

Study Design

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

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 16, 2021
• Study Start: August 16, 2022
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (3)