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HR3 in metastatic or recurrent colorectal cancer

ABSTRACT: Interventions: Group I (Experimental): Nimotuzumab (hR3) 200 mg. Grupo II (Experimental): Nimotuzumab (hR3) 400 mg. Grupo III (Experimental): Nimotuzumab (hR3) 800 mg. Grupo IV (Experimental): Nimotuzumab (hR3) 1200 mg. Nimotuzumab Indication: weekly, for 7 weeks then every 2 weeks (intravenous infusion) by 24 month or until significant toxicity. Primary outcome(s): Incidence of Adverse Events (AE) relating to the administration of Nimotuzumab (AE with causal relationship probable or very likely). Measuring time: in every administration until to complete 2 years of treatment. •Type of AE (name of the adverse event) •Duration of AE (Difference between of start date and the end date of the AE. May be in days, hours or minutes) •Intensity of AE (mild, moderate, severe, Life threatening, death related) •Serious AE (Severe/Serious, not serious/not serious) •Attitude from study treatment (unchanged, dose modification, temporary discontinuation of study treatment, permanent discontinuation of study treatment) •Result of AE (recovered, improved, persist, sequelae) •Causality of the adverse event (Certain, Probable /Likely, Possible, Unlikely, Unrelated) Study Design: Allocation: N/A: single arm study. Masking: Open. Control group: Uncontrolled. Assignment: Single group. Purpose: Treatment

DISEASE(S): Metastatic Or Recurrent Colorectal Cancer

PROVIDER: 2571517 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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