No registrations found.
ID
Source
Brief title
Health condition
Rectal cancer
Rectumcarcinoom
Endeldarmkanker
Sponsors and support
Intervention
Outcome measures
Primary outcome
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).
Secondary outcome
- Patient safety: grade 3-4 complications (NCI-CTCAE version 4.0) or symptoms lasting more than two days.
- Visibility of fiducial markers on MRI and CT
- Migration of fiducial markers
Background summary
NA
Study objective
The aim of this study is to evaluate the feasibility of endoscopic guided placement of gold markers in rectal cancer patients.
An effective and safe endoscopic placement of fiducial markers in the rectum may benefit the imaging of the rectal tumor for radiotherapy purposes (position verification and target volume delineation).
Study design
The study participation of the patient will end after the TME.
Intervention
Patients will undergo an (endoscopic ultrasound (EUS) guided) endoscopy during which two to three gold markers will be inserted in the upper and lower border of the tumour and in the center of the tumour.
Five additional cone beam CT scans and one or two additional MRI scans will be made for evaluation of the fiducial markers.
M.E. Leerdam, van
Amsterdam
The Netherlands
020-5122566
m.v.leerdam@nki.nl
M.E. Leerdam, van
Amsterdam
The Netherlands
020-5122566
m.v.leerdam@nki.nl
Inclusion criteria
• Histologically proven diagnosis of primary rectal adenocarcinoma
• Resectable rectal cancer
o cT1-3N1 / cT3N0 with extramural invasion >5 mm
o Distance to mesorectal fascia >1 mm
• No evidence of distant metastasis
• Treatment options: 5 x 5 Gray (Gy) neoadjuvant radiotherapy followed by TME; Chemoradiation consisting of 25 x 1,8 Gy combined with Capecitabine 825 mg/m2 twice daily followed by TME; 5x5 Gy RT followed by chemotherapy (with or without a subsequent TME)
• Written informed consent
Exclusion criteria
• Coagulopathy (prothrombin time < 50% of control; partial thromboplastin time > 50 seconds) or anticoagulantia (marcoumar or sintrom) that cannot be stopped
• Prior pelvic irradiation or surgery
• 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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4473 |
| NTR-old | NTR4606 |
| CCMO | NL46483.031.14 |
| OMON | NL-OMON41313 |