A LA CART

A LA CART
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Trial Status

Completed

Cancer Type

Rectal Cancer

Protocol Title

Australasian Laparoscopic Cancer of the Rectum Trial: a phase III prospective randomised trial comparing laparoscopic-assisted resection versus open resection for rectal cancer.

Purpose of the Study

A La CaRT is the largest Australian trial in rectal surgery and aims to see if a less disruptive surgery can offer a safer and more effective option. Surgery that uses a medical instrument, called a laparoscope, is a potential new treatment option for rectal cancer. Laparoscopic-assisted resection (surgery which involves a laparoscope and performed under the guidance of a video camera) is also known as keyhole surgery.

The primary aim of the A La CaRT study was to determine whether laparoscopic-assisted resection is non-inferior to open rectal resection as a safe, effective oncologic approach to rectal cancer. Other objectives assessed whether laparoscopic resection for rectal cancer is not inferior to open resection from a patient related benefit perspective, based on morbidity, mortality associated with surgery, disease-free survival and disease recurrence, quality of life, cost effectiveness and MRI staging accuracy.

Key Eligibility Criteria

Inclusion Criteria

Histological diagnosis of adenocarcinoma of the rectum
Age, 18 years and over
Written informed consent.
Life expectancy of at least 12 weeks.

Exclusion criteria

Medical or psychiatric conditions that compromise the patient’s ability to give informed consent or comply with the study protocol.
Pregnancy or breast feeding.
Any uncontrolled concurrent medical condition.
Any co-morbid disease that would increase risk of morbidity.

More Information

To find out more information about this trial, visit ANZTCR for more detailed information.

Principal Investigator

A/Prof Andrew Stevenson

Funding

Colorectal Surgical Society of Australia and New Zealand (CSSANZ)
National Health & Medical Research Council (NHMRC)
GICI New Zealand

Download the Trial Results

Trial Status

Completed

Cancer Type

Rectal Cancer

Protocol Title

Australasian Laparoscopic Cancer of the Rectum Trial: a phase III prospective randomised trial comparing laparoscopic-assisted resection versus open resection for rectal cancer.

Publication Reference

Stevenson AR, Solomon MJ, Lumley JW, Hewett P, Clouston AD, Gebski VJ, Davies L, Wilson K, Hague W, Simes J. Effect of laparoscopic-assisted resection vs open resection on pathological outcomes in rectal cancer: the ALaCaRT randomized clinical trial. JAMA 2015; 314(13): 1356–1363.

Conference Presentation Reference

Warwick AM, Bernardi MP, Davies L, Stevenson ARL. Comparing three modes of rectal dissection for cancer: open vs laparoscopic vs transanal total mesorectal excision. European Society of Coloproctology 11th Congress; 28–30 Sep 2016; Milan.
Stevenson A, Solomon P, Hewett J, Lumley A, Hague W, Gebski V, Wilson K, Simes J. A La CaRT: Australasian laparoscopic cancer of the rectum trial. A phase III randomised trial comparing laparoscopic-assisted resection versus open resection for rectal cancer. Tripartite Colorectal Meeting; 30 Jun–3 Jul 2014; Birmingham.
Stevenson A, Hewett P, Lumley J, Clouston A, Simes J, Hague W, Gebski V, Quiene S, Wilson K, Solomon M. A La CaRT: Australasian Laparoscopic Cancer of the Rectum Trial: a phase III prospective randomised trial comparing laparoscopic-assisted resection versus open resection for rectal cancer. Clinical Oncological Society of Australia (COSA) Annual Scientific Meeting; 9–11 Nov 2010; Melbourne.

Aim

The primary aim of the A La CaRT study is to determine whether laparoscopic-assisted resection is non-inferior to open rectal resection as a safe, effective oncologic approach to rectal cancer. Other objectives are to determine whether laparoscopic resection for rectal cancer is not inferior to open resection from a patient related benefit perspective, based on morbidity, mortality associated with surgery, disease-free survival and disease recurrence, quality of life, cost effectiveness and MRI staging accuracy.

Background

Surgical resection is the most important treatment for rectal cancer not only in terms of offering a possible cure and best prognosis but in terms of treatment options that are available following surgery. In recent years, there has been an increase in the use of laparoscopic surgery for rectal cancer in Australia but without reliable evidence of its safety, efficacy and long-term effectiveness when compared with open surgery. While there are potential advantages of laparoscopic surgery – in terms of less time in hospital, smaller scars and less post-operative morbidity – these advantages are less established for the treatment of rectal cancer.

Before laparoscopic procedures could be recommended as standard, it is essential that reliable evidence is obtained which shows laparoscopic surgery is at least equivalent to open surgery in terms of pathological results, patient-rated and long-term clinical outcomes. Studies have shown that surgical technique and the adequacy of resection predicts local recurrence rates in open rectal surgery and the quality of surgical technique and resection should be as relevant in laparoscopic rectal resection.

The purpose of the A La CaRT study is to compare these two types of surgeries and to determine whether the technique of laparoscopic-assisted resection is as safe and effective as the current standard of open laparotomy and resection in the treatment of rectal cancer.

This study will also determine whether disease recurrence rates are improved and whether patients with rectal cancer benefit through improved short and long-term recovery and overall quality of life.

The A La CaRT trial is currently in the follow up stage and has provided results that will help patients and doctors in the future. Study results were not clear cut between the two surgical options. The primary outcome of successful resection was achieved in 82% in laproscopic surgery group and 89% in open surgery group. Therefore, laproscopic resection was not non-inferior to open resection with respect to successful resection.

There were no differences between the two surgical groups in length of stay, intensive care unit stay, analgesic requirements and other major complications. Small percentages (less than 10%) of patients had problems after the surgery, such as a delayed return to normal bowel function, fever, bleeding and anastomotic leaks, requiring medical attention. Surgeons will be able to use the evidence from this and similar trials to decide whether patients should have laparoscopic or open surgery. Because the results have shown that, in some cases, laparoscopic surgery may not remove the tumour as effectively as open surgery, they will be cautious in their choices.

The results have been published in the Journal of the American Medical Association in 2015. Long term follow up is required to assess the effect of the surgery on recurrence and survival. Trial patients will be followed up with clinic visits and test for 5 years to assess the effect of surgery on recurrence of the cancer, survival and other outcomes. Results will be published in 2020.

Clinical Trial Design

The A La CaRT trial is a multicentre, randomised phase III trial. The study is a non-inferiority trial, meaning that the trial is not testing or comparing which treatment is better but rather whether it was no worse than the traditional treatment.

Eligible participants include patients with rectal tumours who will be randomised to two groups. One group will receive standard open surgery (laparotomy) and rectal resection and other group will receive laparoscopic-assisted rectal resection (keyhole surgery).

Patients will be assessed 6 weeks prior to surgery, with follow up checks at day-3 and day-14 post surgery, and then at 4 to 6 weeks. Further assessment will occur at 3 months, 6 months, 9 months, 12 months, 18 months, 24 months and annually at 3, 4 and 5 years.

Contact Email

ALACART@ctc.usyd.edu.au