This pilot study will evaluate the feasibility of endoscopic guided placement of gold markers in rectal cancer patients including:- Technical success of fiducial marker placement by (EUS guided) endoscopy- Visibility of fiducial markers on MRI and…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
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, 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 outcome
A secondary aim of this study is to evaluate the intrafraction movement of the
rectum as visualized on cone beam CT scan.
Background summary
Neo-adjuvant radiotherapy - in addition to total mesorectal excision - improves
local control of rectal cancer. However, patients experience long-term side
effects after neo-adjuvant radiotherapy, such as fecal incontinence and
impaired sexual functioning.
A reduction in target volume may lead to less side effects and less
treatment-induced mortality. However, target delineation remains difficult for
rectal cancer due to poor visibility of the tumour and target coverage is
difficult due to tumour motion. Fiducial markers may improve radiotherapy
treatment planning and position verification and may provide an opportunity for
a reduction in radiotherapy target volume. Fiducial markers are used for
position verification in other cancers, such as prostate cancer. The clinical
value of fiducial markers in rectal cancer radiotherapy has not been assessed.
Study objective
This pilot study will evaluate the feasibility of endoscopic guided placement
of gold markers in rectal cancer patients including:
- Technical success of fiducial marker placement by (EUS guided) endoscopy
- Visibility of fiducial markers on MRI and CT
- Migration of fiducial markers
- Patient safety of marker placement
Study design
Prospective interventional study in the Netherlands Cancer Institute - Antoni
van Leeuwenhoek, Amsterdam and the Leiden University Medical Center, Leiden.
Intervention
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 tumour or in the tumour area. Five
additional cone beam CT scans and one or two additional MRI scans will be made
for evaluation of the fiducial markers.
Study burden and risks
Participation in this pilot study consists of the placement of two to three
fiducial markers during an (EUS guided) endoscopy in the week prior to
radiotherapy. The procedure will last about 10 minutes and will include very
low risks of rectal pain, bleeding or infection after the procedure. In
addition to standard imaging for radiotherapy treatment planning and position
verification, five additional cone beam CT scans and one or two additional MRI
scans, will be made for study purposes.
Plesmanlaan 121
Amsterdam 1066CX
NL
Plesmanlaan 121
Amsterdam 1066CX
NL
Listed location countries
Age
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)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL46483.031.14 |
| OMON | NL-OMON20605 |