Pilot study evaluating the feasibility of endoscopy guided fiducial marker placement for rectal cancer.

Completed

• Conditions: rectal cancer; rectal carcinoma; 10017990; 10017991

• Registration Number: NL-OMON41313
• Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

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 <=1 mm
and/or
* cN2 / extramesorectal pathological lymph nodes
OR
o 5x5 Gy RT followed by chemotherapy (with or without a subsequent TME)
* rectal cancer with resectable liver metastases
• Written informed consent

Exclusion Criteria

• Coagulopathy (prothrombin time < 50% of control; partial thromboplastin 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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The feasibility of fiducial marker placement, defined as the technical success<br /><br>(the ability to successfully place the fiducials at the desired locations in<br /><br>the tumour area, without grade 3-4 complications or symptoms lasting more than<br /><br>two days), the visibility of fiducial markers on MRI and CT, the migration of<br /><br>fiducial markers and the patient safety of marker placement. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>A secondary aim of this study is to evaluate the intrafraction movement of the<br /><br>rectum as visualized on cone beam CT scan. </p><br>