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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

296 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-30

Study Completion Date

2020-12-31

Brief Summary

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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 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.

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Detailed Description

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Conditions

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Metastatic Colorectal Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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mCRC: Anti-EGFR MAbs + FOLFOX 1st line

• Adult (\>= 18 years old) RAS wild-type metastatic colorectal cancer patients candidate to receive FOLFOX plus panitumumab or FOLFOX plus cetuximab as upfront treatment as per clinical practice.

No interventions assigned to this group

mCRC: Anti EGFR MAbs + FOLFIRI 1st line

Adults (\>= 18 years old) RAS wild-type metastatic colorectal cancer patients candidate to receive FOLFIRI plus panitumumab or FOLFIRI plus cetuximab as upfront treatment as per clinical practice

No interventions assigned to this group