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

Metastatic Colorectal Cancer Clinical Trial

— SILQ  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02624895
• Other study ID #: 20140383
• Status: Completed
• Start date: December 30, 2015
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2021
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 296
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Locations

Country	Name	City	State
Italy	Research Site	Brescia
Italy	Research Site	Castellana Grotte
Italy	Research Site	Castellanza (VA)
Italy	Research Site	Catania
Italy	Research Site	Cona FE
Italy	Research Site	Confreria - Cuneo
Italy	Research Site	Crema
Italy	Research Site	Fano PU
Italy	Research Site	Foggia
Italy	Research Site	Frattamaggiore NA
Italy	Research Site	Isernia
Italy	Research Site	L Aquila
Italy	Research Site	Lecce
Italy	Research Site	Mirano VE
Italy	Research Site	Napoli
Italy	Research Site	Palermo
Italy	Research Site	Poggibonsi SI
Italy	Research Site	Potenza
Italy	Research Site	Rionero In Vulture (PZ)
Italy	Research Site	Roma
Italy	Research Site	Roma
Italy	Research Site	Roma
Italy	Research Site	Roma (RM)
Italy	Research Site	Sanremo (IM)
Italy	Research Site	Savona
Italy	Research Site	Sora (FR)
Italy	Research Site	Taormina ME
Italy	Research Site	Taranto
Italy	Research Site	Torino
Italy	Research Site	Torino
Italy	Research Site	Viterbo

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EORTC QLQ C30 questionnaire score	-HRQoL will be measured using the EORTC QLQ-C30 questionnaire. EORTC QLQ-C30 scores reported during the treatment will be also expressed as percentage of the scores reported at baseline. The measure unit is the answer score provided by the patient to the questions in the questionnaire	24 months
Primary	QoL questionnaire DLQI questionnaire score	Skin satisfaction will be measured using the DLQI. The DLQI score will also be expressed as a percentage of the maximum possible score of 30. DLQI scores reported during the treatment will be also expressed as percentage of the DLQI scores reported at baseline.The measure unit is the answer score provided by the patient to the questions in the questionnaire	24 months
Primary	%of enrolled subjects, experiencing a specific adverse event according to NCI CTC-AE version 4.0	Tolerability: The toxicity rate, defined as the percentage of patients, relative to the total of enrolled subjects, experiencing a specific adverse event of any grade, according to CTCAE version 4.02.	24 months
Primary	Recording of number of concomitant medications, to prevent or treat dermatological adverse events	Management of dermatological toxicity: concomitant medications, both topical and systemic, adopted to prevent or treat dermatological adverse events will be recorded. The measure is the number of topical and systemic treatment administered for skin toxicity management	24 months
Primary	Time to onset of the dermtological toxicity	Tolerability: Times to onset of dermatological toxicities will be also described. The measure is the times elapsed untill adverse event is occurred (days)	24 months
Primary	Dose reduction	To describe the adherence to the treatment in terms of dose reduction.The measure unit is Number of dose reduction occurred out of standard as per clinical practice treatment scheme.	24 months
Primary	"number of administered cycles"	Evaluate the number of treatment cycles performed by the patients. The measure is the number of cycles administered as per clinical practice scheme indicated in the protocol, by each patient	24 months
Primary	average relative dose intensity of every drug"	Will be evaluated the average dose administered to the patient under treatment the measure units are mg or mg/kg	24 months
Secondary	Score scale on questionnaire answers	To investigate the impact of dermatological adverse events during the treatment with FOLFOX plus anti-EGFR MAbs on patients' skin satisfaction as measured by means of the Dermatology Life Quality Index (DLQI) questionnaire. The measure unit is the score coming from patient answer to questions in the questionnaire	24 months
Secondary	Number of cycles on treatment before and of treatment due to AE	To assess the tolerability of administered treatments The measure unit is the number of cycles on treatment before and of treatment due to AE	24 months
Secondary	dose delay	To describe the adherence to the treatment in terms of dose delays, - the measure unit is Number of dose delay occurred out of standard as per clinical practice treatment scheme	24 months
Secondary	Questionnaire score	To describe the management of dermatological adverse events to assess the effect on skin-related QoL of preemptive Vs reactive treatment of skin toxicities. The measure units is the questionnaire score coming from patient answer to relevant questionnaire administered.	24 months

External Links

•   AmgenTrials clinical trials website