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An Observational Study of Avastin in First Line in Elderly Patients With Metastatic Colorectal Cancer (CASSIOPEE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01555762
First received: March 14, 2012
Last updated: November 1, 2016
Last verified: November 2016
  Purpose
This multicenter, prospective, observational study will evaluate the efficacy and safety of Avastin (bevacizumab) in first-line therapy in elderly patients with metastatic colorectal cancer. Data will be collected from eligible patients for24 months.

Condition
Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non Interventional Study Evaluating Efficacy and Safety in a Cohort of Elderly Patients of First Line Therapy With Avastin ® Regimen for Metastatic Colorectal Cancer.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 36 months ]

Secondary Outcome Measures:
  • Clinical/nutritional profile of elderly patients with metastatic colorectal cancer initiated on Avastin treatment [ Time Frame: at baseline ]
  • Change in autonomy (ADL/IADL questionnaires, Balducci classification) [ Time Frame: from baseline to Month 24 ]
  • Overall survival [ Time Frame: 36 months ]
  • Avastin dosage/regimen [ Time Frame: 36 months ]
  • Safety: Incidence of adverse events [ Time Frame: 36 months ]

Enrollment: 403
Study Start Date: March 2012
Study Completion Date: July 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   75 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Elderly patients with metastatic colorectal cancer initiating first-line treatment with Avastin
Criteria

Inclusion Criteria:

  • Adult patients, >/= 75 years of age
  • Metastatic colorectal cancer
  • Initiating Avastin first-line therapy in combination with chemotherapy

Exclusion Criteria:

  • Previous Avastin therapy
  • Patient participating in a clinical study evaluating a cytotoxic anti-cancer therapy and/or an investigational new drug
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01555762

  Show 146 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01555762     History of Changes
Other Study ID Numbers: ML27829
Study First Received: March 14, 2012
Last Updated: November 1, 2016

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 25, 2017