Management of Metastatic Colorectal Cancer: A Clinical and Patient Perspective

Active, not recruiting

• Conditions: Metastatic Colorectal Cancer

• Registration Number: NCT03935763
• Lead Sponsor: Servier Affaires Médicales

Brief Summary

A Real World Evidence Prospective Cohort Study in the Management of Metastatic Colorectal Cancer: A Clinical and Patient Perspective

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-08
• Study First Submitted: 2019-04-24
• Study First Submitted QC: 2019-05-01
• Study First Posted: 2019-05-02
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-19
• Last Update Posted: 2024-04-22
• Primary Completion: 2024-04-30
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 738

Inclusion Criteria

• Age ≥ 18
• Diagnosis of mCRC
• Having had two disease progressions since diagnosis of first metastasis that led to first systemic treatment.

Exclusion Criteria

• Currently participating in an investigational clinical trial (thus it does not apply to observational cohort studies)
• Currently being treated for other cancer(s)
• Not having mental capacity and/or ability to participate in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival	From date of randomization until the date of death from any cause, assessed up to 24 months months	metastatic Colorectal Cancer (mCRC) overall survival in real world setting

Secondary Outcome Measures

Name	Time	Method
Quality of life using Patients Reported Outcomes	within 18 months from enrollment	Patients Reported Outcomes defined by a modified version of the questionnaire ACCEPTance by the Patients of their Treatment (ACCEPT)
Disease control measured by overall response	within 18 months from enrollment	Overall response to treatment defined by complete and partial response, stable disease, progression of the disease

Trial Locations

Locations (18)

Arcispedale Santa Maria Nuova; 🇮🇹 Reggio Emilia, Italy

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

University Hospital Of Heraklion; 🇬🇷 Heraklion, Greece

Del-Pesti Centrum Korhaz OHII, Szent Laszlo Korhaz Telephely; 🇭🇺 Budapest, Hungary

Klinicki Bolnicki Centar (KBC) Zagreb; 🇭🇷 Zagreb, Croatia

Klinikum Wolfsburg; 🇩🇪 Wolfsburg, Germany

UniversitaetsSpital Zuerich (University Hospital Zurich); 🇨🇭 Zürich, Switzerland

Instituto de Oncología Angel H. Roffo; 🇦🇷 Buenos Aires, Argentina

University Hospital in Hradec Kralove Clinic of Oncology and Radiotherapy; 🇨🇿 Hradec Králové, Czechia

Vasteras Central Hospital; 🇸🇪 Västerås, Sweden

Landeskrankenhaus-Universitaetsklinik; 🇦🇹 Salzburg, Austria

Groupe Hospitalier Pitié Salpêtrière; 🇫🇷 Paris, France

UMC Utrecht; 🇳🇱 Utrecht, Netherlands

Institute Of Oncology Ljubljana; 🇸🇮 Ljubljana, Slovenia

Cancer Research UK, Department of Medical Oncology-The Christie NHS Foundation Trust; 🇬🇧 Manchester, United Kingdom

Centro Des Estudos Egas Moniz - Hospital Santa Maria; 🇵🇹 Lisboa, Portugal

Antwerp University Hospital; 🇧🇪 Edegem, Belgium

The Adelaide & Meath Hospital-Dublin Incorporating The National Children's Hospital; 🇮🇪 Dublin, Ireland