Rectal CancerNAVI-LARRCNCT04512937
Computer Navigation-assisted Surgery for Locally Advanced and Recurrent Rectal Cancer
A study testing Computer-assisted navigation surgery in people with Rectal Cancer, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The aim of this study is to investigate feasibility of computer navigation-assisted surgery in particularly difficult cases of locally advanced (LARC) and recurrent (LRRC) rectal cancer where the standard surgical strategy is expected to result in incomplete tumour removal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Computer-assisted navigation surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- 1 Sep 2020to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with LARC or LRRC (either biopsy verified, or demonstrated on MRI and confirmed by the MDT decision)
- The MDT must deem standard surgical strategy at high risk of resulting in R1/R2 resection and computer-assisted navigation likely to improve the chances of obtaining R0 resection.
- Written informed consent
Who cannot join
- Non-adenocarcinoma malignancies.
- Unresectable distant metastatic disease or unresectable synchronous other malignancy
- Patients deemed unfit to participation according to the MDT.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Oslo University Hospital- The Norwegian Radium Hospital
Oslo, 0424
About this study
The aim of this study is to investigate feasibility of computer navigation-assisted surgery in particularly difficult cases of locally advanced (LARC) and recurrent (LRRC) rectal cancer where the standard surgical strategy is expected to result in incomplete tumour removal. The investigators hypothesize that computer navigation-assisted surgery can facilitate improved anatomic orientation in the pelvis enabling tumour removal with free margins in these cases.
Read the detailed description
Curative treatment of rectal cancer requires surgical removal of the tumour. The key challenge in this surgery is to remove the tumour with free margins - R0 resection. Failure to achieve R0 resection often leads to recurrence, which is associated with risk of long-term suffering, poor quality of life and death for the patients. Achieving R0 resection is most difficult in advanced rectal cancer cases, where the tumour is threatening - and sometimes even growing into - neighbouring organs.
Computer navigation-assisted surgery has typically been implemented where extreme surgical precision is necessary or in surgical fields with high anatomic complexity. In such settings, it contributes to preservation of vital anatomic structures close to the tumour, and ensures completeness of resection in cases of malignant disease.
With this in mind, feasibility of navigation in surgically challenging rectal cancer cases will be investigated in this study. If found feasible, navigation could improve surgical management for patients who otherwise would not have the possibility of cure.
- Conditions
- Rectal Cancer
- Being tested
- Computer-assisted navigation surgery
- Keywords
- Surgery, Computer-Assisted, Feasibility study
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-assisted navigation surgeryDevice
Computer navigation-assisted surgery has two main elements; the pre-procedural planning to create accurate 3D images of the pelvis allowing the surgical team to achieve an accurate perception of the operative field, and intraoperative navigation where these images are used for anatomical guidance to enhance surgical precision. Accordingly, computer software is used in this study to outline the tumour and other pelvic organs on pre-operative images which are subsequently used for intraoperative navigation.
| Study group | Role | What they receive |
|---|---|---|
| All patients | Experimental | All patients will be subjects to the intervention of computer navigation-assisted surgery Receives: Device: Computer-assisted navigation surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients with R0 resection
Resection status will be determined by histopathological examination of specimen
Measured: 2 years
Secondary outcomes (8)
Assessment of whether pre-procedural plan was executed during surgery by comparing pre- and post-operative magnetic resonance imaging (MRI).
Postoperative MRI of the pelvis will be examined and compared to preoperative MRI to evaluate what structures were removed at surgery.
Measured: 2 years
Assessment of whether pre-procedural plan was executed by comparing volume of intended resection with volume of resected specimen.
Volume of intended resection (measured in millilitres) based on pre-procedural MRI will be comparted with volume of resected specimen (measured in millilitres).
Measured: 2 years
Assessment of surgeons' opinion on benefit of computer navigation through qualitative interviews.
Interviews with the surgeons will be semi-structured based on an interview guide. They will be recorded and transcribed, and analyzed using thematic analysis.
Measured: 2 years
Occurrence of 30 day morbidity and mortality assessed with the Accordion severity grading system of surgical complications
The Accordion severity grading system of surgical complications classifies surgical complications in 6 Levels ranging from mild complications (1) to Death (6)
Measured: 30 days after surgery
Assessment of patients quality of life using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
The EORTC QLQ-C30 comprises 30 items (i.e. single questions) registering five functioning scales (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain and nausea/vomiting) and one global health status scale. EORTC QLQ C30 will be completed prior to surgery, and at one and three years after surgery. Changes over time will be analysed.
Measured: 3 years
Overall survival (OS)
OS is defined as time from surgery until death from any cause
Measured: 5 years
Rate of local (re-)recurrence after surgery
Local (re)-recurrence will be determined by routine follow-up
Measured: 5 years
Progression-free survivial (PFS)
PFS is defined as time from surgery until disease progression or death from any cause
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start1 Sep 2020
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kjersti Flatmark, Oslo University Hospital
- Investigators
- Kjersti Flatmark, Professor, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04512937
- Sponsor's protocol ID
- 2020/123753
- Acronym
- NAVI-LARRC
- Status last verified
- Nov 2022
- First submitted
- 6 Aug 2020
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Navigation-assisted Surgery for Locally Advanced and Recurrent Rectal Cancer
- ClinicalTrials.gov ID
- NCT04512937
- Acronym / sponsor ID
- NAVI-LARRC / 2020/123753
- Conditions
- Rectal Cancer
- Keywords
- Surgery, Computer-Assisted, Feasibility study
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 14 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate feasibility of computer navigation-assisted surgery in particularly difficult cases of locally advanced (LARC) and recurrent (LRRC) rectal cancer where the standard surgical strategy is expected to result in incomplete tumour removal. The investigators hypothesize that computer navigation-assisted surgery can facilitate improved anatomic orientation in the pelvis enabling tumour removal with free margins in these cases.
Detailed description
Curative treatment of rectal cancer requires surgical removal of the tumour. The key challenge in this surgery is to remove the tumour with free margins - R0 resection. Failure to achieve R0 resection often leads to recurrence, which is associated with risk of long-term suffering, poor quality of life and death for the patients. Achieving R0 resection is most difficult in advanced rectal cancer cases, where the tumour is threatening - and sometimes even growing into - neighbouring organs.
Computer navigation-assisted surgery has typically been implemented where extreme surgical precision is necessary or in surgical fields with high anatomic complexity. In such settings, it contributes to preservation of vital anatomic structures close to the tumour, and ensures completeness of resection in cases of malignant disease.
With this in mind, feasibility of navigation in surgically challenging rectal cancer cases will be investigated in this study. If found feasible, navigation could improve surgical management for patients who otherwise would not have the possibility of cure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Experimental | Device: Computer-assisted navigation surgeryAll patients will be subjects to the intervention of computer navigation-assisted surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with LARC or LRRC (either biopsy verified, or demonstrated on MRI and confirmed by the MDT decision)
- The MDT must deem standard surgical strategy at high risk of resulting in R1/R2 resection and computer-assisted navigation likely to improve the chances of obtaining R0 resection.
- Written informed consent
Key exclusion criteria (3 listed)
- Non-adenocarcinoma malignancies.
- Unresectable distant metastatic disease or unresectable synchronous other malignancy
- Patients deemed unfit to participation according to the MDT.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer-assisted navigation surgeryComputer navigation-assisted surgery has two main elements; the pre-procedural planning to create accurate 3D images of the pelvis allowing the surgical team to achieve an accurate perception of the operative field, and intraoperative navigation where these images are used for anatomical guidance to enhance surgical precision. Accordingly, computer software is used in this study to outline the tumour and other pelvic organs on pre-operative images which are subsequently used for intraoperative navigation. | Device | All patients |
Primary outcome
Rate of patients with R0 resection
Time frame: 2 years
Resection status will be determined by histopathological examination of specimen
8 secondary outcomes
Assessment of whether pre-procedural plan was executed during surgery by comparing pre- and post-operative magnetic resonance imaging (MRI).
Time frame: 2 years
Assessment of whether pre-procedural plan was executed by comparing volume of intended resection with volume of resected specimen.
Time frame: 2 years
Assessment of surgeons' opinion on benefit of computer navigation through qualitative interviews.
Time frame: 2 years
Occurrence of 30 day morbidity and mortality assessed with the Accordion severity grading system of surgical complications
Time frame: 30 days after surgery
Assessment of patients quality of life using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Time frame: 3 years
Overall survival (OS)
Time frame: 5 years
Rate of local (re-)recurrence after surgery
Time frame: 5 years
Progression-free survivial (PFS)
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kjersti Flatmark, Professor principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-assisted navigation surgery in people with Rectal Cancer, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients with R0 resection (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.