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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01555762
First received: March 14, 2012
Last updated: October 20, 2014
Last verified: October 2014
  Purpose

This multicenter, prospective, observational study will evaluate the efficacy an d safety of Avastin (bevacizumab) in first-line therapy in elderly patients with metastatic colorectal cancer. Data will be collected from eligible patients for 24 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical/nutritional profile of elderly patients with metastatic colorectal cancer initiated on Avastin treatment [ Time Frame: at baseline ] [ Designated as safety issue: No ]
  • Change in autonomy (ADL/IADL questionnaires, Balducci classification) [ Time Frame: from baseline to Month 24 ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Avastin dosage/regimen [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Enrollment: 401
Study Start Date: March 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
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 147 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: NCT01555762     History of Changes
Other Study ID Numbers: ML27829
Study First Received: March 14, 2012
Last Updated: October 20, 2014
Health Authority: France: Commission Nationale de l'Informatique et des Libertés (CNIL)

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on October 28, 2014