Last updated on October 2018

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


Brief description of study

This 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 treatment visit" (28 days (+/- 3 days) from the last cycle). Questionnaires should be completed at the start of the visit, before any study related procedure is done.

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.

Clinical Study Identifier: NCT02624895

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