Protocol title: Short Course Oncology Therapy — A Study of Adjuvant Chemotherapy in Colorectal Cancer
Study Chairs: Dr. Andrew Haydon (The Alfred Hospital, Melbourne VIC); and A/Professor Eva Segelov (St Vincent’s Hospital, Sydney NSW)
Associate Oncology Program Manager: Christine Aiken
Trial Coordinator: Jenna Mitchell
Contact Email: SCOT@ctc.usyd.edu.au
Detailed information available on the Australian and New Zealand Clinical Trials Registry — SCOT
Cancer Australia: $299,775 (2009)
Cancer Council: $99,925 (2009), $99,925 (2010), $94,929 (2011), $4,996 (2012)
Funds for site payments and insurance costs ($234,000) were transferred to AGITG and are reported on the 2010 financial accounts.
The primary objective of the study is to assess the efficacy of 12 weeks of adjuvant chemotherapy versus 24 weeks in terms of 3-year disease free survival (DFS). Secondary objectives include assessing overall survival, comparison of the cost effectiveness of the two treatment arms, toxicity and quality of life.
Colorectal cancer is the second leading cause of cancer mortality in Australia. In 2003 there were approximately 12,536 new cases of colorectal cancer and 4,372 deaths from colorectal cancer overall. Following a complete surgical resection for localised disease, patients face a 40-50% chance of disease relapse depending on the tumour stage. With the exception of a small proportion of patients who will have disease amenable to further curative surgical resection, recurrence will lead to death.
Clinical trials conducted throughout the late 1980’s and early 1990’s established adjuvant 5FU based chemotherapy as the standard of care for resected stage III colon cancer and resulted in a relative reduction in mortality of around 30%. Initially 12 months of therapy was used, but when 6 months of 5FU modulated by folinic acid was shown to be equally effective to 12 months, the shorter regimen was adopted. More recently, 2 phase III studies have demonstrated the increased efficacy of incorporating oxaliplatin into the adjuvant treatment of colon cancer (MOSAIC and C-07) and have established 24 weeks of 5FU and oxaliplatin as the current standard for stage III colon cancer.
However, this increased efficacy is associated with increased toxicity (compared to 5FU based regimens), most importantly potentially long-lasting neurotoxicity as well as a greater expense for the preferred oxaliplatin containing regimen. Small studies have suggested that 12 weeks of adjuvant 5FU based chemotherapy may be less toxic without being less effective, although adjuvant regimens of less than 24 weeks duration have not been adequately studied and cannot be considered a standard of care at present.
The SCOT study aims to definitively answer the question of whether 12 weeks of adjuvant chemotherapy (FOLFOX;oxaliplatin/5-FU or XELOX;oxaliplatin/capecitabine) is as effective as 24 weeks of the identical treatment in reducing cancer recurrence. In addition, if SCOT can establish equivalent efficacy with a shortened duration of adjuvant treatment, it will significantly decrease the financial burden of adjuvant treatment on a population basis, and produce vast benefits in terms of short and long term morbidity.
The SCOT study is an international, multicentre open-label randomised, two-arm, phase III non-inferiority trial. It is being coordinated internationally by the Cancer Clinical Trials Office Scotland (CaCTUS) and the Oncology Clinical Trials Office (OCTO) at the University of Oxford. In Australasia, the study is being sponsored by the AGITG and coordinated by the NHMRC Clinical Trials Centre. 6144 patients will be recruited internationally across centres in Europe and Australia, with 213 patients recruited from ANZ participating sites.
To view the Study Schema click here.