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Brief Title: Cetuximab Rechallenge in Irinotecan-pretreated mCRC, KRAS, NRAS and BRAF Wild-type Treated in 1st Line With Anti-EGFR Therapy (CRICKET).
Official Title: A PHASE II SINGLE-ARM STUDY OF CETUXIMAB PLUS IRINOTECAN AS RECHALLENGE 3RD-LINE TREATMENT OF KRAS, NRAS AND BRAF WILD-TYPE IRINOTECAN-PRETREATED METASTATIC COLORECTAL CANCER PATIENTS PROGRESSING AFTER AN INITIAL RESPONSE TO A 1ST-LINE CETUXIMAB-CONTAINING THERAPY AND A STANDARD 2ND-LINE
Study ID: NCT02296203
Brief Summary: 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
AUSL DI FROSINONE - FROSINONE (FR) ONCOLOGIA MEDICA U.O. Oncologia Medica, Frosinone, , Italy
Irccs Istituto Oncologico Veneto (Iov) - Padova (Pd) Oncologia Medica, Padova, , Italy
Azienda Ospedaliero Universitaria Di Parma - U.O.Oncologia Medica, Parma, , Italy
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
Name: Alfredo Falcone, MD, PhD
Affiliation: U.O. Oncologia Medica 2 Universitaria, Università di Pisa - AOUP, Polo Oncologico, Area Vasta Nord-Ovest, Istituto Toscano Tumori
Role: PRINCIPAL_INVESTIGATOR