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.
Study Chair: Dr Andrew Stevenson (Holy Spirit Northside Medical Centre, Chermside QLD)
Associate Oncology Program Manager: Cheryl Friend
Trial Coordinator: Kate Walker
Contact Email: ALACART@ctc.usyd.edu.au
Detailed information available on the Australian and New Zealand Clinical Trials Registry — A La CaRT
NHMRC Grant: $932,586 (2011)
GICI NZ Grant: $8,000 (2014)
Funds were received by AGITG in 2014 ($195,400) for site payments and insurance costs.
This income and associated expenditure are included in the 2014 Income Statement.
The primary aim of this study is to determine whether laparoscopic-assisted resection is non-inferior to open rectal resection as a safe, effective oncologic approach to rectal cancer. Secondary aims assessing morbidity, mortality associated with surgery, disease-free survival, disease recurrence, quality of life, MRI staging accuracy and an assessment of cost-effectiveness.
Rectal cancer is a major public health concern, particularly in countries such as Australia and New Zealand where the incidence is amongst the highest in the world. 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. There is growing use of laparoscopic surgery for rectal cancer in Australia over recent years, 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 become recommended as standard, it is essential that reliable evidence is obtained that 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. Recently published results support non-inferior short term outcomes in open and laparoscopic-assisted surgical resections for colon cancer with regards to the quality of the resection and recurrence rates. Similar findings may be revealed in rectal cancer, but technique, oncologic outcomes and recurrence patterns must first be systematically evaluated.
This is a multicentre randomised phase III trial. The study requires 470 patients to be randomised to either open laparotomy and rectal resection or laparoscopic-assisted rectal resection.
The study’s objective is to determine whether laparoscopic-assisted resection is not inferior to open rectal resection as a safe, effective oncologic approach to rectal cancer.
Secondary objectives in this study 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 and MRI staging accuracy.
To view Study Schema click here.