Quality assessment of intra-operative radiotherapy in Locally Advanced or Recurrent Rectal Cancer with the use of Image-Guided Navigation

Quality assessment of intra-operative radiotherapy in Locally Advanced or Recurrent Rectal Cancer with the use of Image-Guided Navigation - QUART

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON56733

Enrollment

191

Registered

2024-02-21

Start date

2024-05-22

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colorectal cancer colorectal cancer

Interventions

A medical device (navigational setup) will be used during surgical resection +&nbsp

IORT procedures in patients with abdominopelvic malignancies as surgical tool during the resection and for documentation of the exact IORT beam location and direction. Endpoints will be compared with

retrospective cohort based on previous results from the NKI-AvL.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients who are scheduled for abdominopelvic cancer surgery by laparotomy;Patients in whom resection margins are at risk and IORT is indicated and deemed technically feasible;Patients should have a suitable (contrast enhanced) CT and/or MRI scan available;Signed informed consent;Patients = 18 years old.

Exclusion criteria

Exclusion criteria: Patients with significant distortion of the available medical imaging (CT/MRI) or of the electromagnetic tracking during surgery, for example as a result of metal implants in the pelvic area, to be determined by the involved researcher(s);Patients with a pacemaker and/or cardiac defibrillator.

Design outcomes

Primary

Measure	Time frame
The primary endpoint of this study is in-field local recurrence during 3-year follow-up.	—

Secondary

Measure	Time frame
- R0-R1 resections and tumor extensiveness. - 3-year overall survival, 3-year disease-free survival, 3-year local recurrence-free survival. - Early (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.	—

Measure

Time frame

- R0-R1 resections and tumor extensiveness. - 3-year overall survival, 3-year disease-free survival, 3-year local recurrence-free survival. - Early (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.

—

Countries

Netherlands

Contacts

Public ContactN.C. Morsink

Catharina Ziekenhuis

pco@catharinaziekenhuis.nl0402399111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: May 1, 2026