This is a multicentric, phase II single-arm study in which KRAS, NRAS and BRAF wild-type, irinotecan-resistant metastatic colorectal cancer patients progressing after an initial response to a first-line cetuximab-containing therapy, receive a rechallenge third-line treatment with cetuximab plus irinotecan.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
AUSL DI FROSINONE - FROSINONE (FR) ONCOLOGIA MEDICA U.O. Oncologia Medica
Frosinone, Italy
Irccs Istituto Oncologico Veneto (Iov) - Padova (Pd) Oncologia Medica
Padua, Italy
Azienda Ospedaliero Universitaria Di Parma - U.O.Oncologia Medica
Parma, Italy
percentage of patients achieving a decrease equal or more than 30% in the sum of the longest diameters of target lesions
ORR is defined as the percentage of patients, relative to the total of enrolled subjects, achieving a complete (CR) or partial (PR) response, according to RECIST 1.1 criteria. The determination of clinical response will be based on investigator-reported measurements. Responses will be evaluated with a chest and abdominal computed tomography (CT) scan every 8 weeks. Patients who do not have an on-study assessment will be included in the analysis as non-responders.
Time frame: evaluation every 8 weeks until 48 weeks
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A.O. Universitaria Pisana - Pisa (Pi) Oncologia Medica
Pisa, Italy
AUSL 5 DI PISA - PISA (PI) ONCOLOGIA MEDICA oncologia medica Osp Lotti Pontedera
Pontedera, Italy
Ospedale Fatebenefratelli
Roma, Italy
Azienda Policlinico Umberto I - Oncologia Medica
Roma, Italy
Campus Biomedico
Roma, Italy
A.O. Universitaria S.Maria Della Misericordia Di Udine
Udine, Italy