Cetuximab for Metastatic colorectal cancer | Colorectal adenocarcinoma

Inclusion criteria

• {"criterion_text":"- Histologically proven diagnosis of colorectal adenocarcinoma\n- Signed informed consent obtained before screening.\n- Diagnosis of metastatic disease\n- RAS and BRAF wild-type status of FFPE analysis of primary colorectal cancer and/or related metastasis\n- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST criteria, vers.1.1)\n- Male or female patients ≥ 18 years of age\n- ECOG Performance Status 0,1\n- Adequate bone marrow, liver and renal function assessed within 14 days before starting study treatment as defined by the following parameters:Bone marrow: • Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L • Hemoglobin (Hgb) ≥ 9 g/dL • Platelets ≥ 100 x 109/L Liver function: • Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and ALT (SGPT) ≤ 2.5 x ULN, except in patients with tumor involvement of the liver who must have AST and ALT ≤ 5 x ULN Renal function: • Serum creatinine ≤ 1.5 x ULN or 24-hour clearance ≥ 50 mL/min\n- If female and of childbearing potential, have a negative result on a pregnancy test performed a maximum of 7 days before initiation of study treatment\n- If female and of childbearing potential, or if male, agreement to use adequate contraception (e.g., abstinence, intrauterine device, oral contraceptive, or double-barrier method), during the study and until at least 3 months after last dose of study treatment administration, based on the judgment of the Investigator or a designated associate"}

Exclusion criteria

• {"criterion_text":"- Any contraindication to the use of cetuximab, Irinotecan, 5-FU, oxaliplatin, folinic acid,bevacizumab, trifluridine-tipiracil, regorafenib\n- Previous chemotherapy for the colorectal cancer with the exception of adjuvant treatment, completed at least 6 months before entering the study\n- Participation in a clinical study or experimental drug treatment within 30 days prior to study inclusion or during participation in the study\n- Known or clinically suspected brain metastases\n- History of acute or subacute intestinal occlusion or chronic inflammatory bowel disease or chronic diarrhoea\n- Severe, non-healing wounds, ulcers or bone fractures\n- Uncontrolled hypertension\n- Marked proteinuria (nephrotic syndrome)\n- Known DPD deficiency (specific screening not required)\n- Known history of alcohol or drug abuse\n- A significant concomitant disease which, in the investigating physician's opinion, rules out the patient's participation in the study\n- Active uncontrolled infections, active disseminated intravascular coagulation or history of interstitial lung disease\n- Absent or restricted legal capacity\n- Past or current history of malignancies other than colorectal carcinoma, except for curatively treated basal and squamous cell carcinoma of the skin cancer or in situ carcinoma of the cervix\n- Pregnancy (exclusion to be ascertained by a beta hCG test)\n- Breastfeeding\n- Fertile women (<2 years after last menstruation) and men of childbearing potential not willing to use effective means of contraception•\n- Myocardial infarction, unstable angina pectoris, balloon angioplasty (PTCA) with or without stenting within the past 12 months before inclusion in the study, Grade III or IV heart failure (NYHA classification)\n- Cardiac arrhythmias requiring anti-arrhythmic therapy, with the exception of beta blockers or digoxin\n- Medical or psychological impairments associated with restricted ability to give consent or not allowing conduct of the study"}

Primary endpoints

• {"endpoint_text":"- Response rate (RR) for each line of treatment according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in patients with RAS/BRAF wild type (WT) mCRC.","definition_or_measurement_approach":"Response rate measured according to RECIST v1.1 per line of treatment in patients with RAS/BRAF wild-type mCRC."}

Secondary endpoints

• {"endpoint_text":"- Progression Free Survival (PFS): measured from the start of therapy until the first observation of disease progression or death due to any cause.","definition_or_measurement_approach":"PFS measured from start of therapy until first documented disease progression or death from any cause."}
• {"endpoint_text":"- Overall Survival (OS): calculated from the start of the study treatment until death.","definition_or_measurement_approach":"OS calculated from start of study treatment until death."}
• {"endpoint_text":"- Safety: Adverse events graded according NCI CTCAE v 5.0.","definition_or_measurement_approach":"Safety assessed as adverse events graded per NCI CTCAE v5.0."}
• {"endpoint_text":"- Molecular profiles of tumor tissue and liquid biopsy: molecular analysis of formalin fixed paraffin embedded (FFPE) tumor tissue, which is representative of the primary tumor or of a metastatic site at the diagnosis of mCRC, will be performed before the first line, whilst blood samples for liquid biopsy will be collected before each line of treatment.","definition_or_measurement_approach":"Molecular analysis of FFPE tumor tissue before first-line; liquid biopsy blood samples collected before each treatment line for molecular profiling."}

Italy

Earliest CTIS Part Ii Submission Date

18-10-2024

Latest Decision Or Authorization Date

28-08-2025

Processing Time Days

314

Number Of Sites

24

Number Of Participants

200

Primary sponsor

Full Name

Gruppo Oncologico Dell'Italia Meridionale

Organisation Type

Patient organisation/association

Country Of Registered Address

Italy