Clinical trial · Observational
PREMIUM, Observational Study
Factors Impacting on Efficacy and Compliance to Cetuximab Treatment in First Line WT KRAS Metastatic Colorectal Cancer
NCT01756625CI-TRIAL-00008746unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| First Line WT KRAS mCRC | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- First line WT KRAS mCRC
Primary outcomes (1)
- measure
- To compare PFS rate at 1 year with PFS in clinical studies (ITT and subgroup analysis)
- timeFrame
- 3 years
Secondary outcomes (1)
- measure
- ORR at 1 year (ITT and subgroup analysis)
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * patients participating to clinical trials
References
Publications (1)
- DERIVEDMineur 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. PMID 33347495