Evaluation of IORT accuracy and effectiveness during rectal cancer surgery by determining the exact position and direction of the IORT beam through the use of an intra-operative electromagnetic image-guided navigation system.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of this study is in-field local recurrence during 3-year
follow-up.
Secondary outcome
- R0-R1 resections and tumor extensiveness.
- 3-year overall survival, 3-year disease-free survival, 3-year local
recurrence-free survival.
- Early (<=30 days) and late (>30 days) complications (Clavien-Dindo) and
toxicity (NCI-CTCAE v5.0).
- Evaluation of the accuracy of the navigation system;
- Evaluation of possible improvements of the navigation hardware and software,
especially the handling in preparation towards andduring surgery (extra time
needed to use the navigation system during abdominal surgery will be recorded);
- Evaluation of the potential influence of the navigation system on
intra-operative decision making.
Background summary
In recent years, intraoperative radiotherapy (IORT) is increasingly being used
for the treatment of rectal cancer. However, the efficacy and safety of IORT
for the treatment of rectal cancer remains disputed. Some benefits are seen in
the 5-year local disease control, but these results failed to reach statistical
significance, thus the exact value of IORT remains to be established by further
research. In addition, in these studies, information on the exact localisation
and subsequent alignment of the IORT beam is lacking, leading to the inability
to draw significant conclusions from studies for IORT use in rectal cancer
surgery. This particular study will mainly focus on quality assessment of IORT
by visualisation, marking and documentation of the exact position and direction
of the beam with the use of a navigation system. This will allow for more
feasible comparison of studies using IORT in the future.
Study objective
Evaluation of IORT accuracy and effectiveness during rectal cancer surgery by
determining the exact position and direction of the IORT beam through the use
of an intra-operative electromagnetic image-guided navigation system.
Study design
An interventional study.
Intervention
A medical device (navigational setup) will be used during surgical resection +
IORT procedures in patients with locally advanced and recurrent rectal
carcinoma as surgical tool during the resection and for documentation of the
exact IORT beam location and direction. Endpoints will be compared with a
retrospective cohort based on previous results from the NKI-AvL.
Study burden and risks
No extra noticable burden for the patient. Possibly slightly longer operation
(max. 15 mins.) required for setting up and checking the navigation system,
which is a negligible extension of the relatively long operation duration for
these patients. The only risk is that the system does not function according to
set accuracy limits or shows errors during treatment. This will be monitored
constantly during the operation. In the exceptional case that such errors
cannot be resolved immediately, the surgeon can proceed using the conventional
surgical procedure without use of the medical device.
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Listed location countries
Age
Inclusion criteria
• Patiënt will be treated for locally advanced or recurrent rectal cancer.
• Treatment plan consists of laparotomy with intra-operative radiation therapy.
• Patient has suitable (contrast-enhanced) CT and/or MRI-scan available.
• Patient is older than 18 years.
• Patient provides informed consent to participate in the study.
Exclusion criteria
• Inclusion criteria are not met.
• Metal implants in the pelvic area.
• Pacemaker and/or cardiac defibrillator implanted.
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
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL86388.100.24 |