Computer Navigation-assisted Surgery for Locally Advanced and Recurrent Rectal Cancer (NAVI-LARRC)

November 10, 2022 updated by: Kjersti Flatmark, Oslo University Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0424
        • Oslo University Hospital- The Norwegian Radium Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Non-adenocarcinoma malignancies.
  • Unresectable distant metastatic disease or unresectable synchronous other malignancy
  • Patients deemed unfit to participation according to the MDT.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: All patients
All patients will be subjects to the intervention of computer navigation-assisted surgery
Device: Computer-assisted navigation surgery
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of patients with R0 resection
Time Frame: 2 years
Resection status will be determined by histopathological examination of specimen
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of whether pre-procedural plan was executed during surgery by comparing pre- and post-operative magnetic resonance imaging (MRI).
Time Frame: 2 years
Postoperative MRI of the pelvis will be examined and compared to preoperative MRI to evaluate what structures were removed at surgery.
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
Volume of intended resection (measured in millilitres) based on pre-procedural MRI will be comparted with volume of resected specimen (measured in millilitres).
2 years
Assessment of surgeons' opinion on benefit of computer navigation through qualitative interviews.
Time Frame: 2 years
Interviews with the surgeons will be semi-structured based on an interview guide. They will be recorded and transcribed, and analyzed using thematic analysis.
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
The Accordion severity grading system of surgical complications classifies surgical complications in 6 Levels ranging from mild complications (1) to Death (6)
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
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.
3 years
Overall survival (OS)
Time Frame: 5 years
OS is defined as time from surgery until death from any cause
5 years
Rate of local (re-)recurrence after surgery
Time Frame: 5 years
Local (re)-recurrence will be determined by routine follow-up
5 years
Progression-free survivial (PFS)
Time Frame: 5 years
PFS is defined as time from surgery until disease progression or death from any cause
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oslo University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kjersti Flatmark, Professor, Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2027

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 6, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 14, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020/123753

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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