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NCT03874026phase 2recruiting
Study of Folfiri/Cetuximab in FcGammaRIIIa V/V Stage IV Colorectal Cancer Patients
34
Enrollment · estimated
1
Countries · 1 sites
2023-05
Primary completion
1 yr ago
Record updated
Commercial relevance
No explicit biomarker / molecular-testing language identified in the public record.
Change timeline
Signals from this trial
- New trial42/100Opportunity
New phase 2 trial NCT03874026 posted by National Cancer Institute, Naples: "Study of Folfiri/Cetuximab in FcGammaRIIIa V/V Stage IV Colorectal Cancer Patients".
Eligibility — raw, for validation
Inclusion Criteria: * Cytological or histological diagnosis of colorectal adenocarcinoma; * KRAS, NRAS, BRAF wild-type; * FcγRIIIaV/V genotype; * stage IV; * age \<75 years; * at least 1 measurable lesion; * ECOG (Eastern Cooperative Oncology Group) Performance Status 0 or 1; * life expectancy\> 3 months; * negative pregnancy test for all potentially childbearing women; * written informed consent. Exclusion Criteria: * previous systemic anti-tumor treatment (allowed treatment with capecitabine or fluorouracil and radiotherapy in the neoadjuvant setting of rectal tumors with therapy terminated at least 6 months before); * presence of primary non-treated stenosing colorectal neoplasm; * neutrophils \<2000/mm³ or platelets \<100.000/mm³ or hemoglobin \<9 g/dl; * serum creatinine level\> 1.5 times the maximum normal value; * GOT (glutamic oxaloacetic transaminase) and/or GPT (glutamic pyruvic transaminase) \>5 times the maximum normal value and/or bilirubin level \>3 times the maximum normal value; * previous malignant neoplasms (excluding basal or spinocellular cutaneous carcinoma or in situ carcinoma of the uterine cervix); * active or uncontrolled infections; * other concomitant uncontrolled diseases or conditions contraindicating the study - drugs at clinician evaluation; * presence of brain metastases; * refusal or inability to provide informed consent; * impossibility to guarantee follow-up.