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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04512937
Recruitment Status : Not yet recruiting
First Posted : August 14, 2020
Last Update Posted : August 14, 2020
Sponsor:
Information provided by (Responsible Party):
Kjersti Flatmark, Oslo University Hospital

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Rectal Cancer Device: Computer-assisted navigation surgery Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Computer Navigation-assisted Surgery for Locally Advanced and Recurrent Rectal Cancer
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : September 1, 2027
Estimated Study Completion Date : September 1, 2027

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Rate of patients with R0 resection [ Time Frame: 2 years ]
    Resection status will be determined by histopathological examination of specimen


Secondary Outcome Measures :
  1. 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. 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).

  3. 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.

  4. 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)

  5. 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.

  6. Overall survival (OS) [ Time Frame: 5 years ]
    OS is defined as time from surgery until death from any cause

  7. Rate of local (re-)recurrence after surgery [ Time Frame: 5 years ]
    Local (re)-recurrence will be determined by routine follow-up

  8. Progression-free survivial (PFS) [ Time Frame: 5 years ]
    PFS is defined as time from surgery until disease progression or death from any cause



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04512937


Contacts
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Contact: Arne M. Solbakken, MD +47 48281082 armsol@ous-hf.no
Contact: Kjersti Flatmark, Professor +47 91168466 kfm@ous-hf.no

Sponsors and Collaborators
Oslo University Hospital
Investigators
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Principal Investigator: Kjersti Flatmark, Professor Oslo University Hospital
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Responsible Party: Kjersti Flatmark, Professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT04512937    
Other Study ID Numbers: 2020/123753
First Posted: August 14, 2020    Key Record Dates
Last Update Posted: August 14, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kjersti Flatmark, Oslo University Hospital:
Surgery, Computer-Assisted
Feasibility study
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases