Clinical Trial Details

RoLaCaRT-1: A Randomized Trial of Robotic Surgery versus Laparoscopic Surgery for Colon Cancer

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Trial Information

Broad Health Condition Cancer

Specific Health ConditionBowel - Back passage (rectum) or large bowel (colon)

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,QLD,SA,VIC

Hospital
Sydney Adventist Hospital - Wahroonga
Epworth Richmond - Richmond
Royal Prince Alfred Hospital - Camperdown
Prince of Wales Private Hospital - Randwick
Peter MacCallum Cancer Centre - Melbourne
Cabrini Hospital - Malvern - Malvern
Royal Brisbane & Womens Hospital - Herston
Mater Private Hospital - South Brisbane


Postcode
2076 - Wahroonga
3121 - Richmond
2050 - Camperdown
2031 - Randwick
3000 - Melbourne
3144 - Malvern
4029 - Herston
4101 - South Brisbane


Trial location outside Australia
United States of AmericaMayo Clinic, Rochester Minnesota, Mayo Clinic, Jacksonville, Florida
United KingdomQueen Alexandra Hospital, Portsmouth, St Marks Hospital, London

Anticipated date of first participant enrolment20/08/2021

Anticipated date of last participant enrolment20/08/2021

Phase of TrialPhase 2

Has the study received ethics approval?Further information iconApproved

Trial summary

The aim of this study is to compare the use of robotic surgery with laparoscopic surgery for the surgical treatment of right sided colon cancer.   Robotic and laparoscopic operations are called minimally invasive surgery, that is, they use instruments fitted in through small incisions or cuts in the abdomen.  The removal of the colon cancer tumour called a hemicolectomy and in this study for right-sided colon cancer it is called a right hemicolectomy.

Who is it for?
You may be eligible to join this study if you are an adult aged 18 years and older, have adenocarcinoma (tumour or malignant polyp) of the caecum, ascending or proximal transverse colon that requires surgery. Disease must be confirmed by histological, radiological, endoscopic diagnosis  

Study Details
Participants in this study will be randomly allocated (by chance) to either robotic or laparoscopic surgery.  You will have a two to one chance of be allocated robotic surgery. The purpose of the study is to evaluate the surgery and it’s short and longer term outcomes, quality of life, cost effectiveness and surgeons’ experience with the robotic surgery approach.   All participants will be monitored for up to 12 months for recovery from surgery, adverse events, quality of life and return to usual activities or work.
Eligibility

Key inclusion criteria

1. Adults with adenocarcinoma (tumour or malignant polyp) of the caecum, ascending or proximal transverse colon. Disease must be confirmed by histological, radiological, endoscopic diagnosis.
2. ECOG performance status 0-2.
3. Life expectancy of at least 1 year.
4. Surgery to be performed within 40 days of randomisation.
5. Elective surgery performed with curative intent.
6. Signed, written informed consent.
7. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1. Evidence of T4 disease invading adjacent organs.
2. Pre-operative surgical plan includes division of the middle colic vessels (extended right hemicolectomy) or any other more extensive colectomy procedure.
3. Synchronous surgical procedure planned with right hemicolectomy.
4. Urgent, unplanned or emergency surgery.
5. Palliative surgical intent including non-resection, stoma formation, staging laparoscopy or open and close procedures.
6. Prior formation of defunctioning ileostomy as part of treatment for this right colon cancer.
7. No plan to create a surgical ileo-colonic anastomosis.
8. Neoadjuvant chemotherapy administered to treat this cancer prior to resection.
9. Known Crohn’s disease with active terminal ileal disease.
10. History of any conditions that would preclude use of a minimally-invasive approach (e.g. multiple previous major laparotomies, severe adhesions, patient co-morbidity).
11. Concurrent or previous abdominal or pelvic malignancy within five years prior to registration irrespective of treatment modality.
12. Other co-morbidities or conditions that may compromise assessment of key outcomes.
13. Significant metastatic disease which would be expected to impact life expectancy of at least 1 year
14. Evidence of systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude surgery, or other severe incapacitating disease, i.e. ASA IV (a patient with severe systemic disease that is a constant threat to life) or ASA V (a moribund patient who is not expected to survive without the operation).
15. Pregnancy or lactation. 
Contact details and further information

Sponsor Primary Sponsor Type: Other Collaborative groups
Primary Sponsor Name: Australasian Gastrointestinal Trials Group (AGITG)
Primary Sponsor Address: Level 6, 119 Missenden Rd, Camperdown,2050 NSW Australia.
Primary Sponsor Country: Australia

Trial IDACTRN12620001378910

Contact person for information and recruitmentMs
Kate Wilson
NHMRC Clinical Trials Centre Levels 4-6 Medical Foundation Building, 92-94 Parramatta Rd, Camperdown NSW 2050
+61 2 9562 5000

Further information iconRoLaCaRT@ctc.usyd.edu.au
Australia