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OncoMatch/Clinical Trials/NCT04089631

Circulating Tumour DNA Based Decision for Adjuvant Treatment in Colon Cancer Stage II Evaluation

Is NCT04089631 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Capecitabine for colon cancer stage ii.

Phase 3RecruitingTechnische Universität DresdenNCT04089631Data as of May 2026

Treatment: CapecitabineThe CIRCULATE study evaluates the adjuvant therapy in patients with colon cancer UICC stage II. The primary aim of the study is to compare the disease free survival in patients who are positive for postoperative circulating tumour DNA with vs. without capecitabine.

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Biomarker criteria

Excluded: MSH2 deficiency

mismatch repair deficiency (dMMR)

Excluded: MSH6 deficiency

mismatch repair deficiency (dMMR)

Excluded: MLH1 deficiency

mismatch repair deficiency (dMMR)

Excluded: PMS2 deficiency

mismatch repair deficiency (dMMR)

Excluded: DPYD deficiency

Known dihydropyrimidine dehydrogenase (DPD)-deficiency

Disease stage

Required: Stage II

Excluded: Stage III, IV

Performance status

WHO 0–1

Prior therapy

Must have received: surgery — resection

Resected colon cancer stage II, OR resected rectal cancer stage II

Cannot have received: neoadjuvant therapy

Neoadjuvant therapy before resection

Lab requirements

Blood counts

Leukocytes < 3,0 Gpt/l; Neutrophil granulocytes < 1,5 Gpt/l; Thrombocytes < 100 Gpt/l [excluded]

Kidney function

Creatinine clearance (calculated according Cockcroft-Gault) < 30 ml/min [excluded]

Liver function

alanine aminotransferase (ALAT) or (aspartate aminotransferase) ASAT > 3x ULN [excluded]

Contra indications for chemotherapy, especially: Leukocytes < 3,0 Gpt/l; Neutrophil granulocytes < 1,5 Gpt/l; Thrombocytes < 100 Gpt/l; alanine aminotransferase (ALAT) or (aspartate aminotransferase) ASAT > 3x ULN; Creatinine clearance (calculated according Cockcroft-Gault) < 30 ml/min

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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