rectal cancer rectal carcinoma
Conditions
Interventions
Patients will undergo an (endoscopic ultrasound (EUS) guided) endoscopy during
which two to three gold markers will be implanted in the upper and lower border
of the tumour and in the center of the
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Histologically proven diagnosis of primary rectal adenocarcinoma • Treatment plan: o 5x5 Gray (Gy) neoadjuvant radiotherapy followed by TME * cT1-3N1 / cT3N0 with extramural invasion >5 mm * Distance to mesorectal fascia >1 mm OR o Chemoradiation consisting of 25 x 1,8 Gy combined with Capecitabine 825 mg/m2 twice daily followed by TME * cT4 / cT2-3 with distance to mesorectal fascia
Exclusion criteria
Exclusion criteria: • Coagulopathy (prothrombin time 50 seconds) or anticoagulantia (marcoumar, sintrom or new oral anticoagulants) that cannot be stopped • Prior pelvic irradiation or surgery that may affect the placement of the markers • World health organization performance status 3-4 • Pregnant women • Patients who underwent a hip replacement • Patients with a contraindication for MRI (e.g. pacemaker, metallic foreign body in the eye, cerebral aneurysm clips, claustrophobia)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The feasibility of fiducial marker placement, defined as the technical success (the ability to successfully place the fiducials at the desired locations in the tumour area, without grade 3-4 complications or symptoms lasting more than two days), the visibility of fiducial markers on MRI and CT, the migration of fiducial markers and the patient safety of marker placement. | — |
Secondary
| Measure | Time frame |
|---|---|
| A secondary aim of this study is to evaluate the intrafraction movement of the rectum as visualized on cone beam CT scan. | — |
Countries
Netherlands
Outcome results
None listed