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CETUXIMAB, IRINOTECAN AND FLUOROURACILE IN FIRST-LINE TREATMENT OF IMMUNOLOGICALLY-SELECTED ADVANCED COLORECTAL CANCER PATIENTS - the CIFRA study
EU CTIS ID: 2024-518987-11-00
What this study is testing
To evaluate whether the administration of FOLFIRI/Cetuximab is effective as a first-line treatment for patients with metastatic colorectal cancer, RAS wild-type and FcγRIIIA V/V.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
- Written informed consent
- RAS wild-type
- FcγRIIIa-158V/V genotype
- Stage IV
- Negative pregnancy test, where applicable
You likely can't join if
- 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.
- Refusal or inability to provide informed consent
- Inability to ensure follow-up
- Presence of untreated stenosing primary colorectal neoplasia with the placement of an endoprosthesis
- Neutrophils < 2000/mm³, or platelets < 100,000/mm³, or hemoglobin < 9 g/dl
- Creatinine > 1.5 times the upper normal limit
See the full eligibility criteria
- 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
- Written informed consent
- RAS wild-type
- FcγRIIIa-158V/V genotype
- Stage IV
- Negative pregnancy test, where applicable
- Age < 75 years
- At least one measurable lesion according to RECIST v1.1 criteria
- ECOG Performance Status 0 or 1
- Life expectancy > 3 months
- 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.
- Refusal or inability to provide informed consent
- Inability to ensure follow-up
- Presence of untreated stenosing primary colorectal neoplasia with the placement of an endoprosthesis
- Neutrophils < 2000/mm³, or platelets < 100,000/mm³, or hemoglobin < 9 g/dl
- Creatinine > 1.5 times the upper normal limit
- GOT (AST) and/or GPT (ALT) > 5 times the upper normal limit and/or bilirubin > 3 times the upper normal limit
- Previous malignant neoplasia (excluding basal cell or squamous cell skin carcinoma or in situ carcinoma of the uterine cervix)
- Active or uncontrolled infection
- Other concomitant decompensated or uncontrolled diseases, or conditions that contraindicate the study drugs, at the clinician's discretion
- Presence of brain metastases
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.