An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer: Continued Avastin Plus Chemotherapy After First Progression in Clinical Practice

NCT02287597 | Completed

• 1 other identifier: ML29055
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 4

Brief Summary

This local, non-interventional, cohort study of patients with metastatic colorectal cancer (mCRC) will prospectively collect data from standard clinical practice of second-line treatment with chemotherapy plus Avastin (bevacizumab). There will be no additional diagnostic or therapeutic procedures required by this study, apart from those performed in everyday clinical practice for second-line treatment of mCRC in Croatia.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Effectiveness: Second-line time to progression, in months

  Time between treatment initiation and tumor progression or death from cancer related cause, with censoring of patients who are lost to follow-up; up to 2 years

Secondary Outcomes (2)

• Safety (composite outcome measure): Incidence of all adverse events, adverse events of special interest (AESI) for bevacizumab and pregnancies reported in second line mCRC treatment with Avastin plus chemotherapy

  Up to 2 years

• Safety (composite outcome measure): Incidence, nature and severity of all serious adverse events reported in second line mCRC treatment with Avastin plus chemotherapy and information on outcome and action taken with the drug

  Up to 2 years

Study Arms (1)

Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with metastatic colorectal cancer eligible for second-line chemotherapy and Avastin in Croatia.

You may qualify if:

• Written informed consent
• Age \>/=18 years
• Metastatic colorectal cancer (mCRC) previously treated with systemic treatment for advanced disease containing Avastin and chemotherapy; first-line Avastin received according to the Summary of Product Characteristics (SmPC)
• First line progression-free survival (PFS) \>6 months
• Eligible for second-line chemotherapy regimen
• Period between first progression and start of second line treatment with Avastin and chemotherapy \</=6 weeks

You may not qualify if:

• Contraindications, warnings and precautions for use specified in the Avastin SmPC

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (4)

Clinical Hospital Osijek; Dept For Oncology & Radiotherapy

Osijek, 31000, Croatia

Location

Uni Hospital Split; Oncology & Radiotherapy

Split, 21000, Croatia

Location

Clinical Hospital Centre Zagreb

Zagreb, 10000, Croatia

Location

Uni Hospital For Tumours; Dept of Medical Oncology

Zagreb, 10000, Croatia

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2014
• First Posted: November 10, 2014
• Study Start: November 13, 2014
• Primary Completion: March 21, 2018
• Study Completion: March 21, 2018
• Last Updated: July 30, 2018

Record last verified: 2018-07

Locations

CR (4)