Abstract 157TiP
Background
Despite standard of care management with surgery ± adjuvant chemotherapy treatment (ACT), >30% of patients (pts) with early-stage CRC recur. Detectable ctDNA in plasma has been shown to be a strong prognostic factor for recurrence, suggesting that ctDNA is molecular evidence of residual disease. Analysis of ctDNA may enable post-surgical risk stratification and ACT decision-making, as well as early recurrence detection during surveillance. CORRECT-I aims to validate the association of post-definitive therapy and pre-recurrence follow-up ctDNA with recurrence-free interval (RFI) in stage II-III CRC.
Trial design
This is a prospective, observational study open in Israel, Italy, Japan, Spain and the UK. Eligible pts must have undergone complete surgical resection for stage II or III CRC with tumor tissue available, and not have started ACT. Pts are asked to provide blood specimens for ctDNA at a) post-surgical baseline, b) pre-recurrence follow-up visits (max 15 blood draws over max 5 years), and c) clinical recurrence (if applicable). ctDNA will be analyzed with a NGS-based tumor-informed MRD assay that identifies somatic genomic alterations from DNA derived from the patient’s tumor tissue and detects a selected subset of tumor-specific (bespoke) ctDNA in their blood. The primary objective is to validate the association of post-definitive therapy and pre-recurrence follow-up ctDNA positivity with RFI using a Cox proportional hazards regression analysis. Further objectives include assessment of sensitivity and specificity of the ctDNA assay, association between ctDNA dynamics/individual timepoints and RFI, and time from ctDNA positivity to clinical recurrence. A multivariable model, including ctDNA results, clinicopathological risk features, serial CEA and recurrence risk will be fit with RFI as endpoint. The primary analysis will be conducted when ≥30 histologic/radiographic confirmed cases of a clinical recurrence have been observed. As of April 2, 2024, 158 pts of 400 have been enrolled.
Legal entity responsible for the study
Exact Sciences.
Funding
Exact Sciences.
Disclosure
S. Subramaniam, M.R. Palomares, R.F.L. Baehner, F. De Jong: Financial Interests, Personal, Full or part-time Employment: Exact Sciences. T. Yoshino: Financial Interests, Personal, Invited Speaker: Chugai Pharmaceutical Co., Ltd., Merck Biopharma Co., Ltd., Bayer Yakuhin, Ltd., Ono Pharmaceutical Co., Ltd., MSD K.K., Takeda Pharmaceutical Co., Ltd.; Financial Interests, Personal, Other, Consultancy: Sumitomo Corp.; Financial Interests, Institutional, Research Grant: Ono Pharmaceutical Co., Ltd., Sanofi K.K., MSD K.K., Taiho Pharmaceutical Co., Ltd., Molecular Health GmbH, Amgen K.K., Pfizer Japan Inc., Genomedia Inc., Sysmex Corp., Daiichi Sankyo Co., Ltd., Chugai Pharmaceutical Co., Ltd., Nippon Boehringer Ingelheim Co., Ltd., Eisai Co., Ltd., Roche Diagnostics K.K., Falco Biosystems Ltd. All other authors have declared no conflicts of interest.