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Luciann Nguyen
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NCT03874026phase 2recruiting

Study of Folfiri/Cetuximab in FcGammaRIIIa V/V Stage IV Colorectal Cancer Patients

National Cancer Institute, Naples

ClinicalTrials.gov
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

No changes detected yet. The first refresh records a baseline snapshot; subsequent refreshes generate field-level changes.

Signals from this trial
  • New trial
    42/100
    Opportunity

    New phase 2 trial NCT03874026 posted by National Cancer Institute, Naples: "Study of Folfiri/Cetuximab in FcGammaRIIIa V/V Stage IV Colorectal Cancer Patients".

    ClinicalTrials.gov record updated 670 days ago.

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.