- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02139215
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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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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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The pharmacoeconomic impact of panitumumab for the treatment of metastatic colorectal cancer in a real-life setting
Time Frame: 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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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jean Lachaine, PhD, PeriPharm
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PMPC-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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