Clinical trial NCT02624895: ObservationaL Study on the Qol of RAS Wild-type mCRC Patients Receiving Anti-EGFR MAbs + FOLFOX or FOLFIRI as 1st Line
Official title: ProSpective multIcenter observationaL Study on the Quality of Life of mCRC RAS Wild-type Patients Receiving Anti-EGFR MAbs + FOLFOX or FOLFIRI as 1st Line of Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Colorectal Cancer
Keywords: metastatic colorectal cancer gene RAS not mutated "WILD TYPE"
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2015-12-09
Enrollment: 296
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult (\>= 18 years old) RAS wild-type metastatic colorectal cancer patients candidate to receive FOLFOX or FOLFIRI plus panitumumab or FOLFOX or FOLFIRI plus cetuximab as upfront treatment as per clinical practice. Willingness and ability to comply with the protocol. Written informed consent to study procedures.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:- Adult (\>= 18 years old) RAS wild-type metastatic colorectal cancer patients candidate to receive FOLFOX or FOLFIRI plus panitumumab or FOLFOX or FOLFIRI plus cetuximab as upfront treatment as per clinical practice

* Willingness and ability to comply with the protocol
* Written informed consent to study procedures
* Exclusion Criteria: - Patients receiving a treatment under clinical investigation may not be included in the study
* Previous treatment with an anti-EGFR monoclonal antibody

Primary outcomes:
measure: EORTC QLQ C30 questionnaire score
timeFrame: 24 months
measure: QoL questionnaire DLQI questionnaire score
timeFrame: 24 months
measure: %of enrolled subjects, experiencing a specific adverse event according to NCI CTC-AE version 4.0
timeFrame: 24 months
measure: Recording of number of concomitant medications, to prevent or treat dermatological adverse events
timeFrame: 24 months
measure: Time to onset of the dermtological toxicity
timeFrame: 24 months
measure: Dose reduction
timeFrame: 24 months
measure: "number of administered cycles"
timeFrame: 24 months
measure: average relative dose intensity of every drug"
timeFrame: 24 months
Secondary outcomes:
measure: Score scale on questionnaire answers
timeFrame: 24 months
measure: Number of cycles on treatment before and of treatment due to AE
timeFrame: 24 months
measure: dose delay
timeFrame: 24 months
measure: Questionnaire score
timeFrame: 24 months
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Research Site
city: Castellana Grotte
country: Italy
facility: Research Site
city: Castellanza (VA)
country: Italy
facility: Research Site
city: Catania
country: Italy
facility: Research Site
city: Cona FE
country: Italy
facility: Research Site
city: Confreria - Cuneo
country: Italy
facility: Research Site
city: Crema
country: Italy
facility: Research Site
city: Fano PU
country: Italy
facility: Research Site
city: Foggia
country: Italy
facility: Research Site
city: Frattamaggiore NA
country: Italy
facility: Research Site
city: Isernia
country: Italy
facility: Research Site
city: L Aquila
country: Italy
facility: Research Site
city: Lecce
country: Italy
facility: Research Site
city: Mirano VE
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Palermo
country: Italy
facility: Research Site
city: Poggibonsi SI
country: Italy
facility: Research Site
city: Potenza
country: Italy
facility: Research Site
city: Rionero In Vulture (PZ)
country: Italy
facility: Research Site
city: Roma (RM)
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Sanremo (IM)
country: Italy
facility: Research Site
city: Savona
country: Italy
facility: Research Site
city: Sora (FR)
country: Italy
facility: Research Site
city: Taormina ME
country: Italy
facility: Research Site
city: Taranto
country: Italy
facility: Research Site
city: Torino
country: Italy
facility: Research Site
city: Torino
country: Italy
facility: Research Site
city: Viterbo
country: Italy
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: