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

Colorectal Cancer Metastatic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02139215
• Other study ID #: PMPC-01
• Status: Completed
• First received: May 13, 2014
• Last updated: March 29, 2018
• Start date: April 2014
• Est. completion date: March 2018

Study information

• Verified date: March 2018
• Source: PeriPharm
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer Metastatic
• Colorectal Neoplasms

Locations

Country	Name	City	State
Canada	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 Québec (CHU, Hôtel-Dieu de Québec)	Québec
Canada	Centre Hospitalier Universitaire de Sherbrooke (CHUS)	Sherbrooke	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
PeriPharm	Personalized Medicine Partnership for Cancer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The pharmacoeconomic impact of panitumumab for the treatment of metastatic colorectal cancer in a real-life setting	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.	From the date of registration until date of death from any cause, assessed up to 38 months