None listed
Conditions
Brief summary
This study looks at the effectiveness of surgically removing the primary tumour in patients with colorectal cancer where the cancer has already spread to distant sites. Who is it for? You can join this study if you have cancer of the colon or rectum (bowel) which has spread to further sites in the body. Trial participants will be randomly divided into two groups. One group will follow the standard practice of having surgery to remove the primary cancer, followed by chemotherapy and/or radiotherapy. The other group will receive treatment with chemotherapy and/or radiotherapy alone, reserving surgery until such a time as the disease causes bowel complications, and surgery must be performed to remove the primary tumour. Patients will be assessed before and after receiving treatment and thereafter at 3 monthly intervals until death. Quality of life questionnaires will be repeated at 1, 2, 3, 4,5 and 6 months. Studies suggest that only a minority of patients (approximately 20%) develop serious intestinal complications from the primary tumour, and that it may not be worthwhile subjecting all patients to major surgery at the outset. This study aims to find out optimal management by comparing the two treatments and their impact on overall survival and quality of life. The SUPER study hypothesises that patients with Stage IV colon or rectal cancers receive optimal palliative treatment through the combined use of chemotherapy and/or radiotherapy and do not need to undergo elective resection of the primary tumour. The SUPER study will compare two strategies in the treatment of non-curable, colon or rectal cancer cancer to determine whether the standard practice of initially undergoing surgery to remove the primary cancer followed by chemotherapy and/or radiotherapy offers best management, or whether chemotherapy and/or radiotherapy alone should be offered, reserving surgery until such a time as disease progression results in bowel complications, and surgery to remove the primary tumour must be performed.
Interventions
For this group of patients for whom surgery is palliative, the two different treatment intervention arms are as follows:
a) the standard practice of initially undergoing surgery to remove the primary cancer followed by chemotherapy and/or radiotherapy, or b) treatment with chemotherapy and/or radiotherapy alone, reserving surgery until such a time as disease progression results in bowel complications, and surgery to remove the primary tumour must be performed.
In the first group, surgery to remo
For this group of patients for whom surgery is palliative, the two different treatment intervention arms are as follows: a) the standard practice of initially undergoing surgery to remove the primary cancer followed by chemotherapy and/or radiotherapy, or b) treatment with chemotherapy and/or radiotherapy alone, reserving surgery until such a time as disease progression results in bowel complications, and surgery to remove the primary tumour must be performed. In the first group, surgery to remove the tumour will be performed by open laparotomy and resection, or by laparoscopic (keyhole) resection as per the surgeon's standard practice. Chemotherapy or chemoradiotherapy to follow involves a full course of systemic chemotherapy where systemic therapy comprises optimal treatment as judged by the treating oncologist/radiation oncologist. Treatment may include experimental agents and patients may participate in other chemotherapy clinical trials.
Sponsors
Australasian Gastro-Intestinal Trials Group (AGITG)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Histologically confirmed adenocarcinoma of the colon or rectum (rectal cancers defined as occurring within 15cms of the anal verge). Primary tumour is non-obstructing (i.e. a colonoscope can be passed beyond the tumour). Unresectable metastatic disease as judged by the treating clinicians/multidisciplinary team meeting discussion. Age = 18. Eastern Co-operative Oncology Group (ECOG) performance status 0-2. Adequate organ function: creatinine=1.5x Upper limit of normal (ULN), bilirubin=1.5xULN, Neutrophils=1.5, Platelets=150. Life expectancy of at least 12 weeks. Considered appropriate for systemic chemotherapy. Written informed consent
Exclusion criteria
Bulky metastatic disease as judged by the treating clinician (e.g. >40% of liver replacement). Presence of ascites Previous surgical intervention for colon cancer. Obstructive symptoms requiring immediate surgical intervention. Primary tumour which is clearly un-resectable. Any severe and/or uncontrolled medical conditions that prohibit surgical intervention. Active or uncontrolled severe infection. History of another primary malignancy (exceptions include non melanoma skin cancer, carcinoma insitu of uterine cervix, or any other cancer treated with curative intent without evidence of relapse for > 2 years). Female patients who are pregnant or breastfeeding.
Outcome results
None listed