Study to Evaluate Real-world Pharmacoeconomics of Panitumumab in Metastatic Colorectal Cancer Patients

Completed

• Conditions: Colorectal Cancer Metastatic

• Registration Number: NCT02139215
• Lead Sponsor: PeriPharm

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-05-13
• Study First Submitted QC: 2014-05-13
• Study First Posted: 2014-05-15
• Status Verified: 2018-03
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Last Update Submitted: 2018-03-29
• Last Update Posted: 2018-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The pharmacoeconomic impact of panitumumab for the treatment of metastatic colorectal cancer in a real-life setting	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.

Trial Locations

Locations (5)

CSSS Alphonse-Desjardins (CHAU, Hôtel-Dieu de Lévis); 🇨🇦 Lévis, Quebec, Canada

Centre Hospitalier de l'Université de Montréal (CHUM); 🇨🇦 Montréal, Quebec, Canada

CIUSSS de l'Est-de-l'Île-de-Montréal (Hôpital Maisonneuve-Rosemont); 🇨🇦 Montréal, Quebec, Canada

Centre Hospitalier Universitaire de Sherbrooke (CHUS); 🇨🇦 Sherbrooke, Quebec, Canada

Centre Hospitalier Universitaire de Québec (CHU, Hôtel-Dieu de Québec); 🇨🇦 Québec, Canada