First Line WT KRAS mCRCNCT01756625
PREMIUM, Observational Study
An observational study of First Line WT KRAS mCRC, run by Dr.Laurent Mineur at 1 site in France.
Trial summary
PREMIUM is an observational pharmaco-epidemiologic, transversal, multi-centric, prospective cohort study and with independent investigators. The purpose is to compare PFS in real life with PFS clinical trials and to determine factors impacting efficacy and compliance to cetuximab treatment in first line K-ras… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- First Line WT KRAS mCRC
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2010to Jun 2013
- 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: patients from private and public centers
Who may be able to join
- patients > 18 years old diagnosed with mCRC
- patients naïve for CT excepted for adjuvant setting or trated max 2 cycles CT in first line mCRC with or without cetuximab
- all patients receiving cetuximab in first line treatment associated or not with CT
- patients relapsed < 6 months after an adjuvant therapy
Who cannot join
- patients participating to clinical trials
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Factors Impacting on Efficacy and Compliance to Cetuximab Treatment in First Line WT KRAS Metastatic Colorectal Cancer
PREMIUM is an observational pharmaco-epidemiologic, transversal, multi-centric, prospective cohort study and with independent investigators. The purpose is to compare PFS in real life with PFS clinical trials and to determine factors impacting efficacy and compliance to cetuximab treatment in first line K-ras wild-type (wt) metastatic colorectal cancer.
Read the detailed description
Retrospective studies have shown the influence of some factors on the efficacy of treatment with cetuximab (nicotine, magnesium etc..). No randomized study has compared the mode of administration of weekly and biweekly cetuximab. What are the factors influencing patient compliance? Adverse events, the relation between doctor and patient. PREMIUM will attempt to explore and assess the variables associated with efficacy and compliance to treatment and study practices in France for clinical management.
- Conditions
- First Line WT KRAS mCRC
- Keywords
- cetuximab, nicotine, magnesium
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 |
|---|---|---|
| First line WT KRAS mCRC | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare PFS rate at 1 year with PFS in clinical studies (ITT and subgroup analysis)
Measured: 3 years
Secondary outcomes (1)
ORR at 1 year (ITT and subgroup analysis)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2012 (estimated)
- Study startJan 2010
- Primary completionMar 2012
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for First Line WT KRAS mCRCStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr.Laurent Mineur
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Serono International SA, BESPIM, CHU Nîmes (data analysis)
- Responsible party
- Sponsor-investigator, Dr.Laurent Mineur, Institut Sainte Catherine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01756625
- Sponsor's protocol ID
- PREMIUM
- Status last verified
- Dec 2012
- First submitted
- 20 Dec 2012
- Last updated
- 27 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Mineur L, Francois E, Plassot C, Phelip JM, Miglianico L, Dourthe LM, Bonichon N, Moreau L, Guimbaud R, Smith D, Achille E, Herve R, Bons JM, Remy S, Faroux R, Villing AL, Mahamat A, Rabbia I, Soulie P, Baumgaertner I, Mathe N, Vazquez L, Boustany R. PREMIUM: A French prospective multicenter observational study of factors impacting on efficacy and compliance to cetuximab treatment in first-line KRAS wild-type metastatic colorectal cancer. PLoS One. 2020 Dec 21;15(12):e0243997. doi: 10.1371/journal.pone.0243997. eCollection 2020.
PubMed 33347495
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Impacting on Efficacy and Compliance to Cetuximab Treatment in First Line WT KRAS Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01756625
- Acronym / sponsor ID
- PREMIUM
- Conditions
- First Line WT KRAS mCRC
- Keywords
- cetuximab, nicotine, magnesium
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Dr.Laurent MineurUniversity, hospital or other
- Collaborators
- Merck Serono International SA, BESPIM, CHU Nîmes (data analysis)
- Study start
- Jan 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jun 2013 (estimated)
- First posted
- 27 Dec 2012 (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.
PREMIUM is an observational pharmaco-epidemiologic, transversal, multi-centric, prospective cohort study and with independent investigators. The purpose is to compare PFS in real life with PFS clinical trials and to determine factors impacting efficacy and compliance to cetuximab treatment in first line K-ras wild-type (wt) metastatic colorectal cancer.
Detailed description
Retrospective studies have shown the influence of some factors on the efficacy of treatment with cetuximab (nicotine, magnesium etc..). No randomized study has compared the mode of administration of weekly and biweekly cetuximab. What are the factors influencing patient compliance? Adverse events, the relation between doctor and patient. PREMIUM will attempt to explore and assess the variables associated with efficacy and compliance to treatment and study practices in France for clinical management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| First line WT KRAS mCRC | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients from private and public centers
Key inclusion criteria (4 listed)
- patients > 18 years old diagnosed with mCRC
- patients naïve for CT excepted for adjuvant setting or trated max 2 cycles CT in first line mCRC with or without cetuximab
- all patients receiving cetuximab in first line treatment associated or not with CT
- patients relapsed < 6 months after an adjuvant therapy
Key exclusion criteria (1 listed)
- patients participating to clinical trials
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
To compare PFS rate at 1 year with PFS in clinical studies (ITT and subgroup analysis)
Time frame: 3 years
1 secondary outcome
ORR at 1 year (ITT and subgroup analysis)
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2012.
- Derived from this study: PubMed 33347495Mineur L, Francois E, Plassot C, Phelip JM, Miglianico L, Dourthe LM, Bonichon N, Moreau L, Guimbaud R, Smith D, Achille E, Herve R, Bons JM, Remy S, Faroux R, Villing AL, Mahamat A, Rabbia I, Soulie P, Baumgaertner I, Mathe N, Vazquez L, Boustany R. PREMIUM: A French prospective multicenter observational study of factors impacting on efficacy and compliance to cetuximab treatment in first-line KRAS wild-type metastatic colorectal cancer. PLoS One. 2020 Dec 21;15(12):e0243997. doi: 10.1371/journal.pone.0243997. eCollection 2020.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of First Line WT KRAS mCRC, run by Dr.Laurent Mineur at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 27 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Results are not available in the source record.
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?
To compare PFS rate at 1 year with PFS in clinical studies (ITT and subgroup analysis) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01756625, which also lists 1 linked publication.
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 27 Dec 2012.