Recruitment Complete
Sponsor ID
20140383

ObservationaL study on the Qol of RAS wild-type mCRC patients receiving Anti-EGFR MAbs + FOLFOX or FOLFIRI as 1st lineSILQ

Sponsor ID
20140383
Clinicaltrials.gov ID
NCT02624895
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

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.

Additional Study Details

Phase
N/A
Product
Vectibix/AMG706 Comb
Type
Observational
Masking
N/A
Enrollment
296
Additional Study Details

Protocol Summary

Primary Outcome Measures

EORTC QLQ C30 questionnaire score

Timeframe: 24 months

QoL questionnaire DLQI questionnaire score

Timeframe: 24 months

%of enrolled subjects, experiencing a specific adverse event according to NCI CTC-AE version 4.0

Timeframe: 24 months

Recording of number of concomitant medications, to prevent or treat dermatological adverse events

Timeframe: 24 months

Time to onset of the dermtological toxicity

Timeframe: 24 months

Dose reduction

Timeframe: 24 months

“number of administered cycles”

Timeframe: 24 months

average relative dose intensity of every drug”

Timeframe: 24 months

Secondary Outcome Measures

Score scale on questionnaire answers

Timeframe: 24 months

Number of cycles on treatment before and of treatment due to AE

Timeframe: 24 months

dose delay

Timeframe: 24 months

Questionnaire score

Timeframe: 24 months

Locations

Location
Status
Contact Us
Location
Research Site
Lecce, Italy, 73100
Status
Recruiting
Location
Research Site
Torino, Italy, 10126
Status
Recruiting
Location
Research Site
Torino, Italy, 10153
Status
Recruiting
Location
Research Site
Castellanza (VA), Italy, 21053
Status
Recruiting
Location
Research Site
Cona FE, Italy, 44124
Status
Recruiting
Location
Research Site
Palermo, Italy, 90146
Status
Recruiting
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