CETUXIMAB for Colorectal cancer | Metastatic colorectal cancer

Inclusion criteria

• {"criterion_text":"- Cytological or histological diagnosis of colorectal adenocarcinoma FOLFIRI+Cetuximab in first-line treatment of metastatic colorectal cancer, RAS wild type, and Fc-γRIIIA-V/V"}
• {"criterion_text":"- RAS wild-type"}
• {"criterion_text":"- FcγRIIIa-158V/V genotype"}
• {"criterion_text":"- Stage IV"}
• {"criterion_text":"- Negative pregnancy test, where applicable"}
• {"criterion_text":"- Age < 75 years"}
• {"criterion_text":"- At least one measurable lesion according to RECIST v1.1 criteria"}
• {"criterion_text":"- ECOG Performance Status 0 or 1"}
• {"criterion_text":"- Life expectancy > 3 months"}
• {"criterion_text":"- Written informed consent"}

Exclusion criteria

• {"criterion_text":"- Previous systemic anti-tumor treatment; treatment with Capecitabine or fluorouracil and radiotherapy is allowed in the neoadjuvant setting for rectal cancer, provided that therapy was completed at least 6 months prior."}
• {"criterion_text":"- Presence of untreated stenosing primary colorectal neoplasia with the placement of an endoprosthesis"}
• {"criterion_text":"- Neutrophils < 2000/mm³, or platelets < 100,000/mm³, or hemoglobin < 9 g/dl"}
• {"criterion_text":"- Creatinine > 1.5 times the upper normal limit"}
• {"criterion_text":"- GOT (AST) and/or GPT (ALT) > 5 times the upper normal limit and/or bilirubin > 3 times the upper normal limit"}
• {"criterion_text":"- Previous malignant neoplasia (excluding basal cell or squamous cell skin carcinoma or in situ carcinoma of the uterine cervix)"}
• {"criterion_text":"- Active or uncontrolled infection"}
• {"criterion_text":"- Other concomitant decompensated or uncontrolled diseases, or conditions that contraindicate the study drugs, at the clinician's discretion"}
• {"criterion_text":"- Presence of brain metastases"}
• {"criterion_text":"- Refusal or inability to provide informed consent"}
• {"criterion_text":"- Inability to ensure follow-up"}

Primary endpoints

• {"endpoint_text":"- Activity assessed by RECIST criteria version 1.1","definition_or_measurement_approach":"Assessment of activity using RECIST criteria version 1.1"}

Secondary endpoints

• {"endpoint_text":"- Response duration","definition_or_measurement_approach":""}
• {"endpoint_text":"- PFS will be determined from the date of treatment start until progression.","definition_or_measurement_approach":"Progression-free survival measured from treatment start date until documented progression"}
• {"endpoint_text":"- OS will be measured from treatment start until death from any cause.","definition_or_measurement_approach":"Overall survival measured from treatment start date until death from any cause"}
• {"endpoint_text":"- Toxic effects assessed by CTCAE of the National Cancer Institute, version 4.0, June 14, 2010","definition_or_measurement_approach":"Toxicity graded according to NCI CTCAE v4.0"}

Italy

Earliest CTIS Part Ii Submission Date

14-10-2024

Latest Decision Or Authorization Date

27-11-2024

Processing Time Days

44

Number Of Sites

4

Number Of Participants

34

Primary sponsor

Full Name

IRCCS Istituto Nazionale Tumori Fondazione Pascale

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy