Metastatic Colorectal CancerSILQNCT02624895
ObservationaL Study on the Qol of RAS Wild-type mCRC Patients Receiving Anti-EGFR MAbs + FOLFOX or FOLFIRI as 1st Line
An observational study of Metastatic Colorectal Cancer, run by Amgen at 31 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- How many people
- 296 participants
- Where
- 31 sitesItaly
- Study dates
- 30 Dec 2015to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
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
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
Italy31 sites
Research Site
Brescia, 25124
Research Site
Castellana Grotte, 70013
Research Site
Castellanza (VA), 21053
Research Site
Catania, 95123
Research Site
Cona FE, 44124
Research Site
Confreria - Cuneo, 12100
Research Site
Crema
Research Site
Fano PU, 61032
Research Site
Foggia, 71100
Research Site
Frattamaggiore NA, 80020
Research Site
Isernia, 86170
Research Site
L’Aquila, 67100
Research Site
Lecce, 73100
Research Site
Mirano VE, 30035
Research Site
Naples, 80131
Research Site
Palermo, 90146
Research Site
Poggibonsi SI, 53100
Research Site
Potenza, 85100
Research Site
Rionero in Vulture (PZ), 85028
Research Site
Roma, 00161
Research Site
Roma, 00184
Research Site
Roma, 00189
Research Site
Roma (RM), 00133
Research Site
Sanremo (IM), 18038
Research Site
Savona, 17100
Research Site
Sora (FR), 03039
Research Site
Taormina ME, 98039
Research Site
Taranto, 74123
Research Site
Torino, 10126
Research Site
Torino, 10153
Research Site
Viterbo, 01100
About this study
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
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).
Read more
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.
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- metastatic colorectal cancer gene RAS not mutated "WILD TYPE"
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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
Measured: 24 months
Secondary outcomes (4)
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
Measured: 24 months
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
Measured: 24 months
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
Measured: 24 months
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2015 (estimated)
- Study start30 Dec 2015
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02624895
- Sponsor's protocol ID
- 20140383
- Acronym
- SILQ
- Status last verified
- Jan 2021
- First submitted
- 9 Nov 2015
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02624895
- Acronym / sponsor ID
- SILQ / 20140383
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- metastatic colorectal cancer gene RAS not mutated "WILD TYPE"
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2015 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 9 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
EORTC QLQ C30 questionnaire score
Time frame: 24 months
-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
QoL questionnaire DLQI questionnaire score
Time frame: 24 months
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
%of enrolled subjects, experiencing a specific adverse event according to NCI CTC-AE version 4.0
Time frame: 24 months
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.
Recording of number of concomitant medications, to prevent or treat dermatological adverse events
Time frame: 24 months
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
Time to onset of the dermtological toxicity
Time frame: 24 months
Tolerability: Times to onset of dermatological toxicities will be also described. The measure is the times elapsed untill adverse event is occurred (days)
Dose reduction
Time frame: 24 months
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.
"number of administered cycles"
Time frame: 24 months
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
average relative dose intensity of every drug"
Time frame: 24 months
Will be evaluated the average dose administered to the patient under treatment the measure units are mg or mg/kg
4 secondary outcomes
Score scale on questionnaire answers
Time frame: 24 months
Number of cycles on treatment before and of treatment due to AE
Time frame: 24 months
dose delay
Time frame: 24 months
Questionnaire score
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
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CRC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Colorectal Cancer, run by Amgen at 31 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EORTC QLQ C30 questionnaire score (time frame: 24 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.