anchor Schraa SJ, van Rooijen KL, van der Kruijssen DEW, et al. "Circulating tumor DNA guided adjuvant chemotherapy in stage II colon cancer (MEDOCC-CrEATE): study protocol for a trial within a cohort study." BMC Cancer. 2020;20(1):790. The peer-reviewed protocol for a Dutch randomized 'trial within cohort' (TwiCs) nested in the Prospective Dutch ColoRectal Cancer (PLCRC) cohort (NCT06434896), planning 1,320 stage II colon cancer patients who have NO guideline indication for adjuvant chemotherapy (i.e., the lower-risk stage II population in whom 15-20% still recur). Patients are randomized 1:1; in the experimental arm, post-resection plasma is tested for tumor-informed ctDNA (PGDx elio platform), and ctDNA-DETECTABLE patients are OFFERED adjuvant CAPOX (8 cycles), while ctDNA-negative experimental-arm patients and all control-arm patients follow standard guideline surveillance. The primary endpoint is the proportion of ctDNA-positive patients who accept adjuvant chemotherapy; secondary endpoints include 2- and 5-year recurrence, DFS, OS, time to recurrence, quality of life, and cost-effectiveness. Bearing on the sub-topic: MEDOCC-CrEATE is distinctive within the trial-spine landscape because it is a RANDOMIZED, exactly-in-scope (resected stage II colon cancer) test of the ESCALATION direction — treat-when-ctDNA-positive — which the existing graph's randomized, stage-II-exact evidence (DYNAMIC, nod_ca77eb54) does NOT test, since DYNAMIC randomizes only the omit-when-negative (de-escalation) policy. It therefore speaks directly to the gap the cause's staged open_question (prp_ac67c7bd) names: that the escalation arm of the sub-topic's bidirectional logic rests almost entirely on observational, broader-population sources (GALAXY, BESPOKE, Kotani 2023) where confounding-by-indication cannot be excluded, with no stage-II-restricted randomized escalation result. MEDOCC-CrEATE is the prospective, randomized, stage-II-colon-specific attempt to supply exactly that missing escalation evidence in a guideline-low-risk population, using a different (PGDx, non-Signatera) tumor-informed assay and a different health system (Netherlands) than the Japanese/Australian/US spine members. Notes on bearing/limits: (a) this is the design/protocol paper, not a results readout — it supplies the prespecified randomized framework and hypotheses (primary endpoint is ACT uptake, a behavioral feasibility measure, not RFS/OS), so the AACR 2024 feasibility abstract (Cancer Res 2024;84(6 suppl):5022) and AACR 2025 update (Cancer Res 2025;85(8 suppl 2):CT221) and any eventual recurrence/survival readout are the natural propose_anchor + propose_supersedes follow-ups; (b) scope match on population is exact (resected stage II colon cancer) but it specifically targets the guideline-low-risk subset without a standard ACT indication, so it does not address high-risk stage II in the way PEGASUS/CIRCULATE-US (IIB/IIC) do; (c) the TwiCs design means the control arm is never informed of randomization and the experimental-arm intervention is an OFFER of chemotherapy, so the primary readout measures real-world acceptance under randomized invitation rather than a per-protocol treatment-effect estimate. It complements rather than duplicates the DYNAMIC (de-escalation), GALAXY/BESPOKE/Kotani (observational MRD biology and escalation rationale), and CIRCULATE-Japan/CIRCULATE-US/PEGASUS (high-risk-stage-II/stage-III platform) nodes by being the stage-II-low-risk, randomized, escalation-direction trial that none of those supply.

nod_30c9bfa8-8353-449a-a4f3-4a5c8e359393

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