To study the feasibility of endoscopic placement of fiducial markers and of the use of these markers for image-guided preoperative radiotherapy in patients with gastric cancer.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Feasibility of using fiducial markers in image-guided pre-operative
radiotherapy for patients with gastric cancer.
Secondary outcome
- Success rate of marker implantation;
- Safety of marker implantation;
- Stability of markers over time;
- Visibility of markers on planning CT and CBCT;
- Ability to use the markers for image registration of CBCT with planning CT;
- Potential benefit of fiducial marker-based image-guided radiotherapy.
Background summary
In the first half of 2018, the CRITICS-II study will start, a multicenter
randomized phase-II trial for resectable gastric cancer (EudraCT #
2015-004627-31). For pre-operative radiotherapy, part of two of the three study
arms, the entire stomach with surrounding lymph nodes is included in the
clinical target volume. However, the stomach is a highly mobile organ,
displaying deformation and motion due to breathing, gastrointestinal filling
and peristalsis. Daily CBCT-based patient position verification is used, but
visibility of the stomach on CBCT is limited.
We hypothesize that fiducial markers with high visibility on CT and CBCT
benefit CBCT-based position verification. This will improve accuracy of
pre-operative radiotherapy for gastric cancer patients.
Study objective
To study the feasibility of endoscopic placement of fiducial markers and of the
use of these markers for image-guided preoperative radiotherapy in patients
with gastric cancer.
Study design
This study is a prospective single-arm intervention study.
Intervention
All included patients will undergo endoscopic placement of fiducial markers in
the stomach. In addition, extra imaging will be obtained:
- the daily cone-beam CT scan prior to radiation will be extra long
- weekly, a long cone-beam CT scan will be obtained after irradiation
- in weeks 1, 3 and 5, a CT scan will be obtained.
Study burden and risks
(Burden) Endoscopy-session: if possible this will be combined with the biopsy
endoscopy that each patient receives within the CRITICS-II clinical trial
protocol. Long CBCT scan: adds 2.5 minutes to the daily treatment time. Weekly
post-irradiation CBCT scan: takes place directly after irradiation; adds 4
minutes to the treatment time. In week 1, 3 and 5 a CT scan will be acquired
(20*30 minutes per scan): will be planned directly prior to or directly
following an irradiation session.
(Risks) For this study extra risks are not to be expected. Like all other
endoscopic procedures a bleeding could occur. The infection risk is estimated
low, comparable to the risk of bleeding. The risk of bleeding is estimated low
and, if occurring, assumed to be small and self-limiting (overall risk <1%).
The extra radiation dose from the CT and CBCT scans is small compared to the
treatment radiation dose of 45 Gy (<2%).
(Benefit) For each patient, the markers will be taken into account during daily
patient position verification / position correction.
(Group relatedness) All included patients are patients with gastric cancer
referred for radiotherapy. No minors or incapacitated persons will be included
in the study.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
- Patients with histologically proven primary gastric cancer;
- Referred for pre-operative radiotherapy in the AMC;
- Written informed consent.
Exclusion criteria
- Coagulopathy or platelets level < 40.000;
- Endoscopic suspicion of fistula;
- Endoscopic suspicion of active gastric infections;
- High risk for sedation;
- Unwilling to participate in the study and/or sign informed consent;
- Pregnant;
- Age < 18 years.
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 | NL65080.018.18 |
| OMON | NL-OMON27588 |