DETECT: Target Volume for Rectal Endoluminal Radiation Boosting
Recruiting · NCT04927897 · Observational (researchers observe without assigning treatment) · Lead sponsor: Maastricht Radiation Oncology
View the official record on ClinicalTrials.gov →Interventions studied
RectoscopyScan, e.g. CT (resection specimen)Ultrasound
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 is running
3 locations listed.
- Maastro - Maastricht, Limburg, Netherlands
- Maastricht University Medical Center - Maastricht, Limburg, Netherlands
- Catharina Hospital - Eindhoven, North Brabant, Netherlands