Phase II randomized trial to assess the effect of intensive vs standard adjuvant chemotherapy in localised colon cancer with circulating tumor DNA

Trial details

Who runs it

Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA

Trial code

EU 2024-518131-11-02

Record updated

24 January 2025

Original description

Phase IIa: To analyse the potential effect of FOLFOXIRI as an intensive adjuvant treatment for ctDNA clearance as a surrogate biomarker of treatment efficacy. Phase IIb: To study differences on the conversion rate between an intensive adjuvant treatment (FOLFOXIRI) versus conventional adjuvant therapy (CAPOX).Read full original descriptionShow less

Phase IIa: To analyse the potential effect of FOLFOXIRI as an intensive adjuvant treatment for ctDNA clearance as a surrogate biomarker of treatment efficacy. Phase IIb: To study differences on the conversion rate between an intensive adjuvant treatment (FOLFOXIRI) versus conventional adjuvant therapy (CAPOX).

Inclusion: CIRCULATE-SPAIN-01 trial written informed consent; Age ≥ 18 years and ≤ 75 years; Histologically confirmed diagnosis of operable stage II or stage III Colon Cancer; Postoperative, ctDNA positive; ECOG performance status 0-1; Normal organ functions, as follows: Absolute neutrophil count (ANC) ≥1500/μL Platelets ≥100.000/μL Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L Total bilirubin ≤1.5 x ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 x ULN AST (SGOT) and ALT (SGPT) ≤2.5 x ULN.

Exclusion: Current treatment with another investigational drug or participation in another investigational study; Acute or subacute intestinal occlusion or history of inflammatory bowel disease; Pre-existing neuropathy > grade 1. Known grade 3 or 4 allergic reaction to any of the components of the treatment; Has a known Gilbert Syndrome or UGT1A1 homozygous *28/*28 germline variant; Has a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is required; Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus infection. Note: no testing for Hepatitis B and Hepatitis C is required; Has a known history of active TB (Bacillus Tuberculosis); Macroscopic or microscopic evidence of residual tumor (R1 or R2 resections). Patients should never have had any evidence of metastatic disease (including presence of tumor cells in the peritoneal lavage); Current clinically unresolved cardiovascular disease; History of another neoplastic disease, unless in remission for ≥ 5 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded; Patients having an MSI-H/MMRd tumor are excluded from the study (done according to standard clinical practice); Has a known DPD (DihydroPyrimidine Dehydrogenase) deficiency; Had an incomplete diagnostic colonoscopy and/or polyps’ removal for patients in whom the remaining colon was not removed or explored. Note: Patients with intraoperative complete colonoscopy or early perioperative complete colonoscopy and/or patients with incomplete colonoscopy, but who do have a CT colonoscopy or intraoperative colonoscopy, may be eligible to be recruited in the study; Patient unable to comply with the study protocol owing to psychological, social or geographical reasons; Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study; Inadequate contraception (male or female patients) if of childbearing or procreational potential.

EU CTIS 2024-518131-11-02