Challenge

Calculating the appropriate sample size
for a first of its kind stage-II colon cancer trial

As Chairman of the Department of Biostatistics, Professor Satoshi Teramukai leads a variety of investigator-initiated clinical trials at the Kyoto Prefectural University of Medicine.

With over 35 years experience, hundreds of published papers and thousands of citations, Professor Satoshi Teramukai's innovative work ranges from a Bayesian predictive sample size design for a single-arm exploratory clinical trial, to designing and implementing SACURA, the only randomized-controlled trial focused on adjuvant therapy for stage II colon cancer.

Colorectal cancer has been the most common cancer in Japan since 2015. While adjuvant chemotherapy is the internationally accepted standard of care with established efficacy for stage III colon cancer, its usefulness for stage II disease remains controversial.

To ensure patients are receiving the best treatment following stage II colon cancer surgery, Professor Satoshi Teramukai and his team set out to verify the benefit of adjuvant chemotherapy for stage II colon cancer compared with observation without any adjuvant treatment and to investigate which subgroups benefit from adjuvant chemotherapy.

The challenge they faced was a large sample size would be necessary to confirm any benefit of adjuvant chemotherapy over surgery alone because the recurrence rate is generally low