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SILQ

ObservationaL Study on the Qol of RAS Wild-type mCRC Patients Receiving Anti-EGFR MAbs + FOLFOX or FOLFIRI as 1st Line

Ensayo de AMGEN INC en Cancer colorrectal metastasico.

Más ensayos de: Cáncer colorrectal metastásico.

Fase

no aplica

Estado

Completado

Participantes

296

previstos

Centros

31

Fin del objetivo primario

dic 2020

fecha real

Qué significa cada fase y cada estado.

Estudio observacional. Comenzó en dic 2015.

Qué mide

EORTC QLQ C30 questionnaire score (del registro, en inglés) (24 meses)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a national, multicentric, prospective, observational trial. The decision to prescribe FOLFOX or FOLFIRI plus panitumumab or FOLFOX or FOLFIRI plus cetuximab must have been freely taken by the clinician prior to the study entry for each patient included. Each physician will see his/her patients within the context of routine visits, without any special visit being organised for the purposes of the study. Therefore, the doctor-patient relationship and patient follow-up are not modified. Physicians are totally free to decide on their patients' therapeutic management. EORTC QLQ-C30 and DLQI questionnaires will be completed by the patients at baseline (Day 1 of Cycle 1), at the first day of every other cycle (every 2 weeks) thereafter, and at ""End of Study Visit" (within 28 days from the end of treatment with anti-EGFR or withdrawal from study for any reason). Before every cycle, adverse events will be recorded and graded according to NCI CTCAE v4.0. Treatment's modifications in terms of cycles' delay, dose reductions or drugs' interruptions will be recorded. Concomitant approaches to prevent or treat dermatological toxicities during the treatment will be registered.

Más ensayos de AMGN

Todos los de AMGN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT02624895), actualizada en ene 2021.