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

• Register: ANZCTR
• Last refreshed on: 10 March 2020
• Main ID: ACTRN12609000663257
• Date of registration: 05/08/2009
• Prospective Registration: Yes
• Primary sponsor: Australian Gastro-Intestinal Trials Group (AGITG)
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 09/03/2010
• Target sample size: 470
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12609000663257.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Phase 3

Countries of recruitment

Australia, New Zealand

Contacts

• Name: Ms A La CaRT Trial Coordinator

• Name: Ms A La CaRT Trial Coordinator

Key inclusion & exclusion criteria

Inclusion criteria: a. Histological diagnosis of adenocarcinoma of the rectum (<15cm from the anal verge as measured by rigid sigmoidoscopy).
b. T 1-3 N0 M0, T1-3 N1 M0 or T1-3 N0-1 M1 disease as determined by pre-treatment CT scans and pelvic MRI (or endorectal ultrasound if MRI contraindicated)
i. For evaluation of pelvis: MRI +/-ERUS; or ERUS alone if MRI contra-indicated
ii. For evaluation of abdomen, liver: CT
iii. For evaluation of chest: either CT or CXR

c. For patients with T3 or N1 disease, completion of pre-operative 5FU-based chemotherapy and/or radiation therapy. Capecitabine may be substituted for 5FU.
d. Age = 18 years.
e. ECOG Performance Status: 0, 1 or 2.
f. Written informed consent.
g. Life expectancy of at least 12 weeks.
Exclusion criteria: a.Medical or psychiatric conditions that compromise the patient’s ability to give informed consent or comply with the study protocol.
b.Pregnancy or breast feeding.
c.Any uncontrolled concurrent medical condition.
d.Any co-morbid disease that would increase risk of morbidity.
e.Participation in any investigational drug study within the previous 4 weeks.
f.Evidence of T4 disease extending to circumferential margin of rectum or invading adjacent organs.
g.Evidence of systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude surgery, or other severe incapacitating disease, i.e. as per the grading system of the American Society of Anaesthesiologists (ASA), 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).
h.History of conditions that would preclude use of a laparoscopic approach (e.g. multiple previous major laparotomies, severe adhesions).
i.Concurrent or previous invasive pelvic malignancy (cervical, uterine and rectal) within five years prior to registration.

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

The study compares two types of surgery for rectal cancer stage T 0-3, N 0-1, M 0-laparoscopic-assisted resection versus open resection;
The study compares two types of surgery for rectal cancer stage T 0-3, N 0-1, M 0-laparoscopic-assisted resection versus open resection

Cancer - Bowel - Back passage (rectum) or large bowel (colon)

Intervention(s)

Two types of surgery are currently available in the treatment of rectal cancer: open laparotomy and rectal resection and laparoscopic-assisted rectal resection.

While open laparotomy (an incision into the abdomen) and surgical resection is currently the standard of care for rectal cancer, laparoscopic-assisted resection (“key-hole” surgery to resect the tumour, performed under the guidance of a video camera) has emerged as a new treatment option for rectal cancer. This technique achieves removal of the rectal tumour with minimally invasive surgery, and potentially achieves better recovery and shorter stays in hospital post-operatively.
Patients will be randomised to receive one of the two surgical treatments to remove the primary rectal cancer - i.e. Open Laparotomy and Rectal Resection or Laparoscopic-assisted Rectal Resection.

Primary Outcome(s)

To determine whether laparoscopic-assisted resection is not inferior to open rectal resection as a safe, effective oncologic approach to rectal cancer.[Pre-operative staging and evaluation of disease will be determined by Computerised Tomography (CT) scan, and pelvic Magnetic Resonance Imaging) MRI or CT scan and Endorectal ultrasound. Pathology specimens obtained at surgery will be reviewed by a Pathology Review Committee to assess a composite of oncologic parameters which must be met for surgical resection to be successful. These parameters which form the primary endpoint are:
Circumferential margin greater than or equal to 1mm
Distal resected margin greater than or equal to 2cm (or greater than or equal to 1cm with clear frozen section in the low rectum)
Completeness of total mesorectal excision (TME)]

Secondary Outcome(s)

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 cost effectiveness. The AQoL-8D questionnaire will provide the utility scores needed to calculate QALYs. The direct health care costs of the intervention will be estimated using trial data on hospitalisations and adverse events. The Labour Force and Income Impacts of Illness questionnaire will measure labour force participation and income impacts of illness on patients. This survey will be used to estimate the indirect costs associated with the treatments (i.e. the costs incurred by patients), allowing the study to determine the cost effectiveness of the intervention from a societal perspective. [Pre-operative assessment of clinical status and baseline quality of life questionnaire instruments will be completed within 6 weeks prior to surgery. Follow up visits take place at day 3 and day 14 post surgery, and then at 4-6 weeks, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months and annually at 3,4,and 5 years. Patient morbidity/mortality associated with surgical intervention data is to be collected, disease-free survival and local pelvic recurrence is assessed at 2 years, overall survival is assessed at 5 years, and quality of life assessment is followed to one year. Cost effectiveness data will be collected at baseline, 3 months, 6 months and 12 months. ]

Secondary ID(s)

A La CaRT

Source(s) of Monetary Support

Colorectal Surgical Society of Australia and New Zealand (CSSANZ)

NHRMC / Cancer Australia

Ethics review

Status: Approved
Approval date: 02/09/2009
Contact:

Cancer Institute NSW Clinical Research Ethics Committee

Results

• Results available: Yes
• Date Posted: 13/11/2018
• Date Completed: 14/12/2019