DETECT: Target Volume for Rectal Endoluminal Radiation Boosting
ConditionRectal Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMaastricht Radiation Oncology
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥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.
Disqualifiers
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.
Trial population
Patients with a limited (ycT1-3N0) residual tumor after neoadjuvant radiotherapy or long-course chemoradiotherapy for rectal adenocarcinoma.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Ultrasound
Diagnostic test3D endorectal ultrasound.
Rectoscopy
Diagnostic testRigid rectoscopy.
Scan, e.g. CT (resection specimen)
Other interventionFor some patients, images of the resection specimen (note: NOT of the patients) during the pathological process will be acquired.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Observational3 interventions
Trial outcomes
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.
Time frame
During post-resection pathological analysis (i.e. approximately 14 days post-resection)Secondary outcomes
1
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
Measured per patient in millimeters by the pathology department in the pathologic resection specimens. Microscopic tumor spread perpendicular to the bowel wall and parallel to the bowel wall will be reported separately.
Time frame
During post-resection pathological analysis (i.e. approximately 14 days post-resection)2
Maximum distance of microscopic tumor spread per patient in all directions from the macroscopic tumor remnant in the pathology specimen excluding ypT0 patients
Measured per patient in millimeters by the pathology department in the pathologic resection specimens. For this secondary outcome, this will be reported excluding all ypT0 patients.
Time frame
During post-resection pathological analysis (i.e. approximately 14 days post-resection)3
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
Measured per patient in millimeters by the pathology department in the pathologic resection specimens. For this secondary outcome, this will be reported only for patients with microscopic tumor spread.
Time frame
During post-resection pathological analysis (i.e. approximately 14 days post-resection)4
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
Measured per patient in millimeters by the pathology department in the pathologic resection specimens. For this secondary outcome, this will be reported only for patients with regrowths.
Time frame
During post-resection pathological analysis (i.e. approximately 14 days post-resection)Other outcomes
1
Identification of potential risk factors for the presence and the extent of microscopic tumor spread not yet identified by our meta-analysis
Potential risk factors include among others ycT stage, regrowths/local recurrence, diameter, predominant histologic grade, tumor regression score/grade (pathologically), vascular invasion, lymphatic invasion, perineural invasion, microsatellite instability (MSI) and parameters related to in vivo MR imaging.
Time frame
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 treatment2
Analysis of (re)biopsy material
This includes the biopsy material at time of diagnosis, and also the rebiopsy material for patients with tumor regrowths/local recurrence after an initial clinical complete response and a "watch and wait" approach. These (re)biopsies are a part of the standard diagnostic work-up. Part of this analysis will be performed during this study by reassessment of the histology of the biopsy material and/or if applicable the rebiopsy material.
Time frame
Biopsy material is obtained at time of diagnosis.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Maastricht Radiation Oncology
Lead sponsor
Maastricht University Medical Center
Collaborator
Catharina Ziekenhuis Eindhoven
Collaborator
Source ClinicalTrials.gov