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…
ID
Bron
Verkorte titel
Aandoening
Rectal cancer
Rectumcarcinoom
Endeldarmkanker
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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).
Achtergrond van het onderzoek
NA
Doel van het onderzoek
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).
Onderzoeksopzet
The study participation of the patient will end after the TME.
Onderzoeksproduct en/of interventie
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.
Publiek
M.E. Leerdam, van
Amsterdam
The Netherlands
020-5122566
m.v.leerdam@nki.nl
Wetenschappelijk
M.E. Leerdam, van
Amsterdam
The Netherlands
020-5122566
m.v.leerdam@nki.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• 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)
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4473 |
| NTR-old | NTR4606 |
| CCMO | NL46483.031.14 |
| OMON | NL-OMON41313 |