RoLaCaRT-1
  • RoLaCaRT-1
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Trial Status

Open

Cancer Type

Colorectal Cancer

If you think this trial is relevant to your situation, please contact your Cancer Specialist to discuss further.

Protocol Title

RoLaCaRT-1: Robotic versus Laparoscopic Colon – a Randomized Trial

Purpose of the Study

Removal of the tumour is the most important treatment for colon cancer, giving the best likely health outcome and allowing treatment options that are available following surgery. RoLaCaRT-1 compares the use of robotic surgery with laparoscopic surgery for the surgical treatment of right-sided colon cancer, the study will aim to determine whether the newer robotic technology will allow greater operative advantages which translate to improved rates of “successful surgery” and better patient-oriented clinical outcomes.

Eligibility Criteria

Key inclusion criteria
  1. Adults aged >=18year of 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.
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.)
  15. Pregnancy or lactation.

Contact Email

RoLaCaRT@ctc.usyd.edu.au

DETAILED INFORMATION AVAILABLE

Available online at the Australian New Zealand Clinical Trial Registry (ANZCTR) please click here.

PRINCIPAL INVESTIGATOR

Professor Andrew Stevenson

Funding

Intuitive Surgical

PATIENTS RECRUITED

Click here to access the table and view recruitment data on all AGITG open trials:

Open Trial Recruitment Table

Participating Centres

New South Wales
Sydney Adventist Hospital
Royal Prince Alfred Hospital
Prince of Wales Private Hospital
Queensland
Royal Brisbane and Womens Hospital
St Vincent’s Private Hospital, Northside
South Australia
Queen Elizabeth Hospital
Victoria
Peter MacCallum Cancer Centre
Cabrini Hospital
Epworth Health Care

Trial Status

Open

Cancer Type

Colorectal Cancer

If you think this clinical trial may be relevant to your patient or to discuss further, please contact the Clinical Trial team.

Protocol Title

RoLaCaRT: Robotic versus Laparoscopic Colon – a Randomized Trial

Background

The introduction of new surgical procedures, techniques and technology are often associated with significant increases in health cost both from the capital investment and disposables used per case. There has been a steady increase in the uptake of robotics in colorectal surgery in recent years. This may have important implications in terms of overall impact on healthcare costs to governments, private insurers and to patients. This study aims to determine whether the newer robotic technology will allow greater operative advantages which translate to improved rates of “successful surgery” and better patient-oriented clinical outcomes.

Aims

The aim of this study is to evaluate the clinical outcomes from performing right hemicolectomies robotically compared with routine laparoscopic colectomy in patients with adenocarcinoma (tumour or malignant polyp) of the caecum, ascending or proximal transverse colon.

Participating Centres

New South Wales
Sydney Adventist Hospital
Royal Prince Alfred Hospital
Prince of Wales Private Hospital
Queensland
Royal Brisbane and Womens Hospital
St Vincent’s Private Hospital, Northside
South Australia
Queen Elizabeth Hospital
Victoria
Peter MacCallum Cancer Centre
Cabrini Hospital
Epworth Health Care

Key Eligibility Criteria

Inclusion criteria
1. Adults, aged 18 years and older, adenocarcinoma (tumour or malignant polyp) of the caecum, ascending or proximal transverse colon. Disease must be confirmed by histological, radiological, endoscopic diagnosis
AGITG Working Party, New Concept, Lay Summary Page 3 of 4
2. ECOG performance status 0-2
3. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments
4. Life expectancy of at least 12 weeks
5. Surgery to be performed within 40 days of randomisation
6. Signed, written informed consent

 

Exclusion criteria
1. Evidence of T4 disease invading adjacent organs.
2. History of conditions that would preclude use of a minimally-invasive approach (e.g. multiple previous major laparotomies, severe adhesions).
3. Concurrent or previous invasive hepatic or duodenal malignancy within five years prior to registration.
4. Specific comorbidities or conditions (e.g. psychiatric) or concomitant medications which may increase risk of morbidity
5. Other co-morbidities or conditions that may compromise assessment of key outcomes
6. Participation in any investigational drug study within the previous 4 weeks
7. 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).
8. Pregnancy or lactation. Women must be post-menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration.