Study to Evaluate Real-world Pharmacoeconomics of Panitumumab in Metastatic Colorectal Cancer Patients
A Phase IV Multicenter Trial to Evaluate Real-world Health Outcomes and Economic Impact of Panitumumab Versus Standard-of-care in the Treatment of Patients With Chemotherapy-refractory Metastatic Colorectal Cancer
This is a phase IV multicenter trial to evaluate real-world health outcomes and economic impact of panitumumab versus standard-of-care (SOC) in the treatment of patients with chemotherapy-refractory metastatic colorectal cancer (mCRC).
The study will enable real-life health economics and outcome research (HEOR) to assess the impact of panitumumab in the Quebec population.
The primary objective is to evaluate real-world health outcomes and economic impact of panitumumab in the treatment of patients with chemotherapy-refractory mCRC in comparison with SOC. The secondary objectives are to confirm survival data, to assess the quality of life of patients and to assess the health care resource utilization of patients.
Patients with a mutated KRAS gene will be treated with standard-of-care (SOC) and patients with a non-mutated (wild type) KRAS gene will be treated with panitumumab.
During the course of the study, data will be collected on quality of life and work productivity. Patients will be asked to fill a set of questionnaires at their recruitment in the study and at every 3 months after treatment initiation.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Québec, Canada, G1R 2J6
- Centre Hospitalier Universitaire de Québec (CHU, Hôtel-Dieu de Québec)
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Quebec
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Lévis, Quebec, Canada, G6V 3Z1
- CSSS Alphonse-Desjardins (CHAU, Hôtel-Dieu de Lévis)
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Montréal, Quebec, Canada, H2X 3J4
- Centre hospitalier de l'Universite de Montreal (CHUM)
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Montréal, Quebec, Canada, H1T 2M4
- CIUSSS de l'Est-de-l'Île-de-Montréal (Hôpital Maisonneuve-Rosemont)
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Sherbrooke, Quebec, Canada, J1H 5N4
- Centre hospitalier universitaire de Sherbrooke (CHUS)
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Patients with a histologically confirmed diagnosis of mCRC.
- Immunohistochemical evidence of EGFR expression.
- ECOG performance status of 0, 1 or 2.
- Patients refractory to fluoropyrimidine, oxaliplatin, and irinotecan chemotherapy regimens
- Patients with a wt KRAS scheduled to receive panitumumab as a single agent for the third-line treatment of mCRC or patients with a mt KRAS scheduled to receive SOC for third-line treatment of mCRC.
- Signed and dated IRB-approved informed consent document.
- Ability to read and understand English or French.
- 18 years of age or older.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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The pharmacoeconomic impact of panitumumab for the treatment of metastatic colorectal cancer in a real-life setting
Tidsramme: From the date of registration until date of death from any cause, assessed up to 38 months
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Pharmacoeconomic impact (cost-effectiveness and cost-utility) will be evaluated by questionnaires completed by the patient and caregiver.
These include quality of life, health resource utilization, work productivity and activity impairment, and health questionnaires.
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From the date of registration until date of death from any cause, assessed up to 38 months
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Jean Lachaine, PhD, PeriPharm
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PMPC-01
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