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Chemotherapy for patients with circulating tumour DNA-positive, stage II colon cancer (CIRCULATE): an AIO/ABCSG trial

Background - Adjuvant chemotherapy provides limited benefit in unselected stage II colon cancer. Post-operative circulating tumour DNA (ctDNA) has higher prognostic value than classical clinical markers, with ctDNA positivity indicating an unfavourable outcome. - Patients and methods - Patients with...

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Main Authors: Folprecht, Gunnar (Author) , Stasik, S. (Author) , Reinacher-Schick, A. (Author) , Weiss, L. (Author) , Goekkurt, E. (Author) , Jacobasch, L. (Author) , Conradi, L. (Author) , Kröcher, A. (Author) , Hofheinz, Ralf-Dieter (Author) , Liersch, R. (Author) , Martens, U. M. (Author) , Chater, J. (Author) , Fuchs, M. (Author) , Riera Knorrenschild, J. U. (Author) , Schubert, J. (Author) , Klimova, A. (Author) , Reinhardt, L. (Author) , Sperling, C. (Author) , von Tresckow, J. (Author) , Weitz, J. (Author) , Aust, D. E. (Author) , Tannapfel, A. (Author) , Christmann, J. (Author) , Thiede, C. (Author)
Format: Article (Journal)
Language:English
Published: August 2026
In: Annals of oncology
Year: 2026, Volume: 37, Issue: 8, Pages: 1120-1132
ISSN:1569-8041
DOI:10.1016/j.annonc.2026.05.001
Online Access:Verlag, kostenfrei, Volltext: https://doi.org/10.1016/j.annonc.2026.05.001
Verlag, kostenfrei, Volltext: https://www.sciencedirect.com/science/article/pii/S0923753426001808
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Author Notes:G. Folprecht, S. Stasik, A. Reinacher-Schick, L. Weiss, E. Goekkurt, L. Jacobasch, L. Conradi, A. Kröcher, R.-D. Hofheinz, R. Liersch, U.M. Martens, J. Chater, M. Fuchs, J.U. Riera Knorrenschild, J. Schubert, A. Klimova, L. Reinhardt, C. Sperling, J. von Tresckow, J. Weitz, D.E. Aust, A. Tannapfel, J. Christmann & C. Thiede

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245 1 0 |a Chemotherapy for patients with circulating tumour DNA-positive, stage II colon cancer (CIRCULATE)  |b an AIO/ABCSG trial  |c G. Folprecht, S. Stasik, A. Reinacher-Schick, L. Weiss, E. Goekkurt, L. Jacobasch, L. Conradi, A. Kröcher, R.-D. Hofheinz, R. Liersch, U.M. Martens, J. Chater, M. Fuchs, J.U. Riera Knorrenschild, J. Schubert, A. Klimova, L. Reinhardt, C. Sperling, J. von Tresckow, J. Weitz, D.E. Aust, A. Tannapfel, J. Christmann & C. Thiede 
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520 |a Background - Adjuvant chemotherapy provides limited benefit in unselected stage II colon cancer. Post-operative circulating tumour DNA (ctDNA) has higher prognostic value than classical clinical markers, with ctDNA positivity indicating an unfavourable outcome. - Patients and methods - Patients with Union for International Cancer Control stage II, mismatch repair proficient/microsatellite stable colon cancer were tested for ctDNA using an academic, tumour-informed, next-generation sequencing-based test. ctDNA-positive patients were randomly assigned 2:1 to CHEMO (capecitabine ± oxaliplatin) or observation (OBS). ctDNA-negative patients were randomly assigned 1:4 to OBS or OFF-STUDY. ctDNA results were not disclosed in the OBS group. The primary endpoint was disease-free survival (DFS) in ctDNA-positive patients. All differences were tested using one-sided log-rank tests. The trial ended early due to funding expiry. - Results - From June 2020 to July 2025, 2126 patients were screened in Germany and Austria. Overall, 1396 patients (2.9% ctDNA-positive) were randomly assigned: 1083 to OFF-STUDY, 287 to OBS, and 26 to CHEMO, of whom 81% started therapy. DFS and overall survival (OS) were significantly worse in ctDNA-positive versus ctDNA-negative patients [3-year DFS 52% versus 87%, hazard ratio (HR) 4.28, 95% confidence interval (CI) 2.32-7.93, P < 0.001; 3-year OS 88% versus 98%, HR 5.48, 95% CI 1.64-18.28, P = 0.001]. In the intention-to-treat (ITT) cohort, the between-arm differences were not significant (3-year recurrence 36% versus 62%, HR 0.48, 95% CI 0.17-1.33, P = 0.075; 3-year DFS 61% versus 38%, HR 0.55, 95% CI 0.21-1.48, P = 0.12). In the per-protocol analysis (excluding untreated CHEMO patients), time to recurrence and DFS were improved with CHEMO compared with OBS (3-year recurrence 19% versus 62%, HR 0.23, 95% CI 0.06-0.87, P = 0.009; 3-year DFS 77% versus 38%, HR 0.31, 95% CI 0.09-1.03, P = 0.021). - Conclusion - The primary ITT endpoint was not met, potentially related to the reduced power due to premature trial closure. The per-protocol analysis suggests a benefit from adjuvant therapy in ctDNA-positive patients, supporting ctDNA testing for adjuvant decision making in the future. 
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