An Observational Study on Avastin (Bevacizumab) as First-Line Treatment in Colorectal Cancer Patients With Potentially Resectable Liver Metastases (PICASSO)

Colorectal Cancer Clinical Trial

Official title:

PICASSO Study: a Cohort Study of Patients With Metastatic Colorectal Cancer Treated With Avastin as First-line Therapy for Hepatic Metastases Considered as Potentially Resectable

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01343901
• Other study ID #: ML22999
• Status: Completed
• Phase: N/A
• First received: April 27, 2011
• Last updated: July 1, 2016
• Start date: September 2010
• Est. completion date: June 2015

Study information

• Verified date: July 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission Nationale de l'Informatique et des Libertés (CNIL)
• Study type: Observational

Clinical Trial Summary

This observational study will evaluate the efficacy and safety of Avastin (bevacizumab) as first-line treatment in patients with colorectal cancer and potentially resectable liver metastases. Data will be collected from each from each patient for 36 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >/= 18 years of age

• Colorectal cancer with exclusively hepatic or hepatic and pulmonary metastases

• First-line treatment with Avastin for potentially resectable metastatic disease

Exclusion Criteria:

• Outright resectable disease

• Clearly inoperable disease

• Participation in a clinical trial evaluating a cytotoxic anticancer treatment and/or an innovative therapy

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate, defined as rate of patients without detectable metastases (after 1st-line treatment with or without surgery)		approximately 4 years	No
Secondary	Clinical characteristics (diagnosis, treatments, comorbidities) of patients initiated on Avastin treatment		approximately 18 months	No
Secondary	Response (no detectable metastases after 1st-line treatment with or without surgery) according to clinical characteristics (number of cycles, chemotherapy, comorbidity)		approximately 4 years	No
Secondary	Progression-free survival		approximately 4 years	No
Secondary	Relapse-free survival after surgery		approximately 4 years	No
Secondary	Overall survival		approximately 4 years	No
Secondary	Histo-pathologic response (assessed at surgery)		approximately 4 years	No
Secondary	Treatment schedules (dosage, intervals, number of cycles)		approximately 4 years	No
Secondary	Safety: Incidence of adverse events		approximately 4 years	No