Clinical trial NCT04512937: Computer Navigation-assisted Surgery for Locally Advanced and Recurrent Rectal Cancer
Official title: Computer Navigation-assisted Surgery for Locally Advanced and Recurrent Rectal Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Rectal Cancer
Keywords: Surgery, Computer-Assisted
Feasibility study
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2020-08-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Rate of patients with R0 resection
timeFrame: 2 years
Secondary outcomes:
measure: Assessment of whether pre-procedural plan was executed during surgery by comparing pre- and post-operative magnetic resonance imaging (MRI).
timeFrame: 2 years
measure: Assessment of whether pre-procedural plan was executed by comparing volume of intended resection with volume of resected specimen.
timeFrame: 2 years
measure: Assessment of surgeons' opinion on benefit of computer navigation through qualitative interviews.
timeFrame: 2 years
measure: Occurrence of 30 day morbidity and mortality assessed with the Accordion severity grading system of surgical complications
timeFrame: 30 days after surgery
measure: 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)
timeFrame: 3 years
measure: Overall survival (OS)
timeFrame: 5 years
measure: Rate of local (re-)recurrence after surgery
timeFrame: 5 years
measure: Progression-free survivial (PFS)
timeFrame: 5 years
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital- The Norwegian Radium Hospital
Study officials:
affiliation: Oslo University Hospital
name: Kjersti Flatmark, Professor
role: PRINCIPAL_INVESTIGATOR
References: