Protocol Title

Short Course Oncology Therapy (SCOT) – A Study of adjuvant chemotherapy in colorectal cancer.

Conference Presentation Reference

1. Iveson T, Kerr R, Saunders MP, Hollander NH, Tabernero J, Haydon AM, Glimelius B, Harkin A, Scudder C, Boyd K, Waterston AM, Medley LC, Wilson C, Ellis R, Essapen S, Dhadda AD, Harrison M, Falk S, Raouf S, Paul J. Final DFS results of the SCOT study: an international phase III randomised (1:1) non-inferiority trial comparing 3 versus 6 months of oxaliplatin based adjuvant chemotherapy for colorectal cancer. American Society of Clinical Oncology; 2–6 Jun 2017; Chicago.
2. Shi Q, Sobrero AF, Shields AF, Yoshino T, Paul J, Taieb J, Sougklakos I, Kerr R, Labianca R, Meyerhardt JA, Bonnetain F, Watanabe T, Boukovinas I, Renfro LA, Grothey A, Niedzwiecki D, Torri V, Andre T, Sargent DJ, Iveson T. Prospective pooled analysis of six phase III trials investigating duration of adjuvant (adjuv) oxaliplatin-based therapy (3 vs 6 months) for patients (pts) with stage III colon cancer (CC): The IDEA (International Duration Evaluation of Adjuvant chemotherapy) collaboration. American Society of Clinical Oncology Annual Meeting; 2–6 Jun 2017; Chicago.
3. Paul J, Briggs A, Harkin A, Haydon AM, Iveson T, Masterson M, Midgley RA, Cassidy J. SCOT: Short Course Oncology Therapy—A comparison of 12 and 24 weeks of adjuvant chemotherapy in colorectal cancer. Journal of Clinical Oncology 2011; 29 (suppl.). Abstract e14145.
4. Haydon A, Price T, Jefford M, Walpole E, Yip D, Ransom D, Jeffery M, Tebbutt N, Wong N, Wollin B, Segelov E. SCOT: Short Course Oncology Therapy—a study of adjuvant chemotherapy in colorectal cancer. Clinical Oncological Society of Australia (COSA) Annual Scientific Meeting; 9–11 Nov 2010; Melbourne.
5. Segelov E, Haydon A, Price T, Jefford M, Walpole E, Yip D, Ransom D, Jeffery M, Tebbutt N, Wong N. SCOT: short course oncology therapy— a study of adjuvant chemotherapy in colorectal cancer. Clinical Oncological Society of Australia (COSA) Annual Scientific Meeting; 9–11 Nov 2010; Melbourne. Asia-Pacific Journal of Clinical Oncology 2010; 6(suppl 3): 181. Abstract 289.

Aim

The primary objective of SCOT trial is to assess the efficacy of 12 weeks of adjuvant chemotherapy versus 24 weeks in terms of 3-year disease free survival. Secondary objectives include assessing overall survival, comparison of the cost effectiveness of the two treatment arms, toxicity and quality of life.

Background

Colorectal (large bowel) cancer is the second most commonly diagnosed cancer in Australia. It is estimated that there will be over 16,000 new cases of colorectal cancer diagnosed in 2017.

Despite complete surgical resection of localised disease, there is still a 40% to 50% chance of disease relapse. Combined chemotherapy post-surgery is the standard of care for patients to reduce the incidence of cancer recurrence. Previous 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 treatment  has been associated with increased toxicity (compared to 5FU based regimens); more specifically, potentially long-lasting neurotoxicity. In addition, the longer timeframe also results in greater financial burden on the patient. Small studies suggest that chemotherapy regimens of less than 24 weeks may be less toxic but still retain effectiveness in preventing disease relapse. However, this has not been adequately studied.

The aim of SCOT trial is to evaluate the safety and efficacy of adjuvant chemotherapy (FOLFOX: oxaliplatin/5-FU or XELOX: oxaliplatin/capecitabine) for 12 weeks versus 24 weeks in reducing cancer recurrence in patients with stage III or high-risk stage II colorectal cancer. In addition, if SCOT can establish equivalent efficacy with a shortened duration of adjuvant treatment, it will significantly reduce the financial burden for the patient and produce vast benefits in terms of short and long-term morbidity associated with treatment.

Clinical Trial Design

SCOT 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.

Eligible participants in this trial will be allocated randomly to one of the two groups. Both groups will be receiving combination chemotherapy of either oxapliplatin/5-FU or oxaliplatin/capecitabine. The choice of combination chemotherapy will be decided by the participant’s medical practitioner.

Participants in one group will undergo chemotherapy for 12 weeks. Participants in the other group will undergo chemotherapy for 24 weeks.

The study participants will be regularly assessed for a period of up to 9 years to determine disease free survival, overall survival, toxicity, cost effectiveness and quality of life. During this period they will have study assessments which includes, clinical examination, carcinoembryonic Antigen test, computed tomography (CT) scans, evaluation of toxicity through physical evaluation and patient reports.

Please note:

The trial results were presented at ASCO 2017. The abstract and oral presentation at ASCO 2017 showed that 3 months of adjuvant chemotherapy was non-inferior to 6 months of chemotherapy for patients with high risk stage II or stage III colorectal cancer; however the non-inferiority was only demonstrated with CAPOX regimen and not FOLFOX.

Study Chairs

Dr. Andrew Haydon (The Alfred Hospital, Melbourne VIC)
Professor Eva Segelov (Monash Health, Monash University VIC)

Contact Email

Principal Investigator

Dr. Andrew Haydon

More Information

Available online at the Australian New Zealand Clinical Trial Registry (ANZCTR) here.

Funding

Cancer Australia
Cancer Council