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NCT Number: NCT02139215

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

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.

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Key information

Conditions

Colorectal Cancer Metastatic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

PeriPharm

Other

Collaborators

  • Personalized Medicine Partnership for Cancer

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
May 15, 2014
Registry last updated
Mar 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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