RecruitingNCT04927897
DETECT: Target Volume for Rectal Endoluminal Radiation Boosting
DETECT: Defining the Target Volume for Endoluminal Radiation Boosting in Patients With Rectal Cancer
Sponsor
Maastricht Radiation Oncology
Enrollment
50 participants
Start Date
Aug 16, 2022
Study Type
OBSERVATIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria5
- ≥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 Criteria5
- 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.
Interventions
DIAGNOSTIC_TESTUltrasound
3D endorectal ultrasound.
DIAGNOSTIC_TESTRectoscopy
Rigid rectoscopy.
OTHERScan, e.g. CT (resection specimen)
For some patients, images of the resection specimen (note: NOT of the patients) during the pathological process will be acquired.
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04927897
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