Capecitabine for Colon cancer (stage II-III)

Inclusion criteria

• {"criterion_text":"- CIRCULATE-SPAIN-01 trial written informed consent."}
• {"criterion_text":"- Age ≥ 18 years and ≤ 75 years."}
• {"criterion_text":"- Histologically confirmed diagnosis of operable stage II or stage III Colon Cancer."}
• {"criterion_text":"- Postoperative, ctDNA positive."}
• {"criterion_text":"- ECOG performance status 0-1."}
• {"criterion_text":"- 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 criteria

• {"criterion_text":"- Patients having an MSI-H/MMRd tumor are excluded from the study (done according to standard clinical practice)."}
• {"criterion_text":"- Acute or subacute intestinal occlusion or history of inflammatory bowel disease."}
• {"criterion_text":"- Pre-existing neuropathy > grade 1. Known grade 3 or 4 allergic reaction to any of the components of the treatment."}
• {"criterion_text":"- Has a known DPD (DihydroPyrimidine Dehydrogenase) deficiency."}
• {"criterion_text":"- Has a known Gilbert Syndrome or UGT1A1 homozygous *28/*28 germline variant."}
• {"criterion_text":"- Has a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is required."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Has a known history of active TB (Bacillus Tuberculosis)."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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)."}
• {"criterion_text":"- Current treatment with another investigational drug or participation in another investigational study"}
• {"criterion_text":"- Patient unable to comply with the study protocol owing to psychological, social or geographical reasons."}
• {"criterion_text":"- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study."}
• {"criterion_text":"- Inadequate contraception (male or female patients) if of childbearing or procreational potential."}
• {"criterion_text":"- Current clinically unresolved cardiovascular disease."}

Primary endpoints

• {"endpoint_text":"- Phase IIa: Proportion of patients who negativize ctDNA after treatment.","definition_or_measurement_approach":"Proportion of ctDNA-positive patients who become ctDNA-negative after treatment (ctDNA clearance as surrogate biomarker of treatment efficacy)."}
• {"endpoint_text":"- Phase IIb: Proportion of patients who negativize ctDNA after treatment in intensive group versus standard of care.","definition_or_measurement_approach":"Comparison of proportion of ctDNA-positive patients who become ctDNA-negative after treatment between the intensive (FOLFOXIRI) and standard (CAPOX) treatment groups."}

Secondary endpoints

• {"endpoint_text":"- Phase IIb:Disease-free survival comparison between both treatment groups 24 months after treatment.","definition_or_measurement_approach":"Disease-free survival assessed at 24 months after end of treatment; comparison between treatment arms."}
• {"endpoint_text":"- Phase IIb: Disease-free survival comparison between both treatment groups 12 months after treatment.","definition_or_measurement_approach":"Disease-free survival assessed at 12 months after end of treatment; comparison between treatment arms."}
• {"endpoint_text":"- Phase IIb: Proportion of patients treated with triplet combination chemotherapy of FOLFOXIRI presenting adverse events in comparison to conventional adjuvant treatment (CAPOX).","definition_or_measurement_approach":"Proportion of patients experiencing adverse events on FOLFOXIRI versus CAPOX; toxicity assessment according to standard AE grading."}
• {"endpoint_text":"- Phase IIb: QLQ-C30 Quality of Life of Cancer Patients and QLQ – CR29, comparison scores between groups at baseline, 3 months and end of treatment.","definition_or_measurement_approach":"Quality of life measured using EORTC QLQ-C30 and QLQ-CR29 at baseline, 3 months, and end of treatment; comparison between groups."}

Spain

Earliest CTIS Part Ii Submission Date

23-01-2025

Latest Decision Or Authorization Date

24-01-2025

Processing Time Days

1

Number Of Sites

8

Number Of Participants

124

Primary sponsor

Full Name

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

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain