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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01343901
First received: April 27, 2011
Last updated: May 23, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition
Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:

Drug Information available for: Bevacizumab
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Response rate, defined as rate of patients without detectable metastases (after 1st-line treatment with or without surgery) [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]

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

Enrollment: 221
Study Start Date: September 2010
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with colorectal cancer and hepatic or hepatic and pulmonary metastases only

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01343901

  Show 119 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01343901     History of Changes
Other Study ID Numbers: ML22999
Study First Received: April 27, 2011
Last Updated: May 23, 2013
Health Authority: France: Commission Nationale de l'Informatique et des Libertés (CNIL)

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013