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Trial record 73 of 318 for:    colon cancer | ( Map: Canada )

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
Sponsor:
Collaborator:
Personalized Medicine Partnership for Cancer
Information provided by (Responsible Party):
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.


Condition or disease
Colorectal Cancer Metastatic

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Study Type : Observational
Actual Enrollment : 72 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Drug Information available for: Panitumumab




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with chemotherapy-refractory metastatic colorectal cancer from participating hospitals in Quebec.
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Canada, Quebec
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
Canada
Centre Hospitalier Universitaire de Québec (CHU, Hôtel-Dieu de Québec)
Québec, Canada, G1R 2J6
Sponsors and Collaborators
PeriPharm
Personalized Medicine Partnership for Cancer
Investigators
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Principal Investigator: Jean Lachaine, PhD PeriPharm

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Responsible Party: PeriPharm
ClinicalTrials.gov Identifier: NCT02139215     History of Changes
Other Study ID Numbers: PMPC-01
First Posted: May 15, 2014    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Panitumumab
Antineoplastic Agents, Immunological
Antineoplastic Agents