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
Australian Gastro-Intestinal Trials Group (AGITG)
470 participants
Mar 9, 2010
Interventional
Conditions
Summary
This study compares surgery using a laparoscope (keyhole surgery) compared with open surgery in treating colorectal (bowel) cancer. You can join this study if you have been diagnosed with primary cancer of the rectum or lower bowel (stage T 1-3 N 0-1 M 0-1) that requires surgery. Trial participants will be randomly divided into two groups. One group will receive surgery using a laparoscope (keyhole surgery) while the other will receive the standard open 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 4–6 weeks, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months and annually at 3, 4 and 5 years. Surgical resection of the tumour is the most important treatment for rectal cancer. Laparoscopic-assisted techniques allow the tumour to be removed with smaller incisions, and less invasive surgery. This study aims to determine whether these new techniques offer a safe and viable alternative to standard surgery. The primary aim of this study will be to determine whether laparoscopic-assisted resection of rectal cancer is non-inferior (or equivalent) in safety and efficacy to the open technique of laparotomy and surgical resection. The secondary aim of the study will be to determine whether laparoscopic-assisted rectal resection is equivalent to open rectal resection in providing comparable recovery outcomes and in terms of disease recurrence and survival, and quality of life.
Eligibility
Inclusion Criteria10
- 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 Criteria9
- 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.
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Interventions
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.
Locations(1)
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ACTRN12609000663257