Study to Evaluate Real-world Pharmacoeconomics of Panitumumab in Metastatic Colorectal Cancer Patients
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|ClinicalTrials.gov Identifier: NCT02139215|
Recruitment Status : Completed
First Posted : May 15, 2014
Last Update Posted : March 30, 2018
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.
|Condition or disease|
|Colorectal Cancer Metastatic|
|Study Type :||Observational|
|Actual Enrollment :||72 participants|
|Official Title:||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|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||March 2018|
|Actual Study Completion Date :||March 2018|
- 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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02139215
|CSSS Alphonse-Desjardins (CHAU, Hôtel-Dieu de Lévis)|
|Lévis, Quebec, Canada, G6V 3Z1|
|CIUSSS de l'Est-de-l'Île-de-Montréal (Hôpital Maisonneuve-Rosemont)|
|Montréal, Quebec, Canada, H1T 2M4|
|Centre Hospitalier de l'Université de Montréal (CHUM)|
|Montréal, Quebec, Canada, H2X 3J4|
|Centre Hospitalier Universitaire de Sherbrooke (CHUS)|
|Sherbrooke, Quebec, Canada, J1H 5N4|
|Centre Hospitalier Universitaire de Québec (CHU, Hôtel-Dieu de Québec)|
|Québec, Canada, G1R 2J6|
|Principal Investigator:||Jean Lachaine, PhD||PeriPharm|