SCOPE1

The SCOPE1 trial tested a drug called cetuximab alongside chemotherapy and radiotherapy for cancer of the food pipe (oesophageal cancer).

If oesophageal cancer has not spread to other parts of the body, doctors may suggest that a patient is treated with a combination of chemotherapy and radiotherapy. This is called chemoradiotherapy.

This trial looked at having cetuximab as well as chemoradiotherapy. Cetuximab is a type of biological therapy, called a monoclonal antibody.

The aims of the trial were to:

• see if adding cetuximab to chemoradiotherapy helped people with oesophageal cancer
• learn more about the side effects.

Results

The trial team found that adding cetuximab to chemoradiotherapy did not help people with oesophageal cancer and caused more side effects.

The trial recruited 258 people with oesophageal cancer that hadn’t spread to other parts of the body. Their average age was 67. Everybody had the chemotherapy drugs cisplatin and capecitabine as well as 5 weeks of radiotherapy. Half the people taking part also had cetuximab.

The committee set up to monitor the safety of the trial analysed some early results from the first 180 people recruited to the trial. They looked at how many people were alive with no signs of cancer in their food pipe or elsewhere in their body 12 weeks after finishing treatment.

They found this was:

• 79 out of 119 people who had chemoradiotherapy and cetuximab
• 93 out of 121 people who had chemoradiotherapy only.

As these results showed that adding cetuximab was not helping, they stopped recruiting people to the trial. The trial team continued to follow up the people who had already joined.

They found that on average, the overall length of time people lived was:

• just over 22 months in the group of people who had chemoradiotherapy and cetuximab
• over 25 months in the group who had chemoradiotherapy alone.

They also found that people who had cetuximab had more side effects, particularly skin problems. Also more people in the cetuximab group stopped having chemoradiotherapy because of side effects or illness than in the chemoradiotherapy only group.

The trial team concluded that adding cetuximab to chemoradiotherapy cannot be recommended as treatment for oesophageal cancer.

Related publications

• Crosby, T. et al., 2017. Long-term results and recurrence patterns from SCOPE-1: a phase II/III randomised trial of definitive chemoradiotherapy +/? cetuximab in oesophageal cancer. British Journal of Cancer 116 (6), pp.709-716. (10.1038/bjc.2017.21)
• Carrington, R. et al., 2016. The influence of radiotherapy treatment method on dose distribution and its relation to patient outcome in the SCOPE 1 oesophageal cancer trial using Type B algorithms. Radiation Oncology (London, England) 11 19. (10.1186/s13014-016-0594-x)
• Crosby, T. D. L. et al. 2013. Chemoradiotherapy with or without cetuximab in patients with oesophageal cancer (SCOPE1): a multicentre, phase 2/3 randomised trial. The Lancet Oncology 14 (7), pp.627-637. (10.1016/S1470-2045(13)70136-0)
• Hurt, C. N. et al. 2011. SCOPE1: a randomised phase II/III multicentre clinical trial of definitive chemoradiation, with or without cetuximab, in carcinoma of the oesophagus. BMC Cancer 11 (1), pp.466. (10.1186/1471-2407-11-466)
• Gwynne, S. et al., 2011. Inter-observer variation in outlining of pre-trial test case in the SCOPE1 trial: A United Kingdom definitive chemoradiotherapy trial for esophageal cancer. International Journal of Radiation Oncology - Biology - Physics 81 (2), pp.S67-S68. (10.1016/j.ijrobp.2011.06.135)