ObservationaL Study on the Qol of RAS Wild-type mCRC Patients Receiving Anti-EGFR MAbs + FOLFOX or FOLFIRI as 1st Line
SILQ
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
1 other identifier
observational
296
1 country
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2015
Longer than P75 for all trials
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2015
CompletedFirst Posted
Study publicly available on registry
December 9, 2015
CompletedStudy Start
First participant enrolled
December 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedJanuary 22, 2021
January 1, 2021
5 years
November 9, 2015
January 20, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
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
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
%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
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
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
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
"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
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 Outcomes (4)
Score scale on questionnaire answers
24 months
Number of cycles on treatment before and of treatment due to AE
24 months
dose delay
24 months
Questionnaire score
24 months
Study Arms (2)
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.
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
Eligibility 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.
You may qualify if:
- Willingness and ability to comply with the protocol
- Written informed consent to study procedures
You may not qualify if:
- Previous treatment with an anti-EGFR monoclonal antibody
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (31)
Research Site
Brescia, 25124, Italy
Research Site
Castellana Grotte, 70013, Italy
Research Site
Castellanza (VA), 21053, Italy
Research Site
Catania, 95123, Italy
Research Site
Cona FE, 44124, Italy
Research Site
Confreria - Cuneo, 12100, Italy
Research Site
Crema, Italy
Research Site
Fano PU, 61032, Italy
Research Site
Foggia, 71100, Italy
Research Site
Frattamaggiore NA, 80020, Italy
Research Site
Isernia, 86170, Italy
Research Site
Lecce, 73100, Italy
Research Site
L’Aquila, 67100, Italy
Research Site
Mirano VE, 30035, Italy
Research Site
Napoli, 80131, Italy
Research Site
Palermo, 90146, Italy
Research Site
Poggibonsi SI, 53100, Italy
Research Site
Potenza, 85100, Italy
Research Site
Rionero in Vulture (PZ), 85028, Italy
Research Site
Roma, 00161, Italy
Research Site
Roma, 00184, Italy
Research Site
Roma, 00189, Italy
Research Site
Roma (RM), 00133, Italy
Research Site
Sanremo (IM), 18038, Italy
Research Site
Savona, 17100, Italy
Research Site
Sora (FR), 03039, Italy
Research Site
Taormina ME, 98039, Italy
Research Site
Taranto, 74123, Italy
Research Site
Torino, 10126, Italy
Research Site
Torino, 10153, Italy
Research Site
Viterbo, 01100, Italy
Related Links
Biospecimen
not collected
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2015
First Posted
December 9, 2015
Study Start
December 30, 2015
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
January 22, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study
- Access Criteria
- Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request