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An Observational Study of Avastin (Bevacizumab) in Elderly Patients With Non-Squamous Non-Small Cell Lung Cancer in Clinical Practice

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ClinicalTrials.gov Identifier: NCT01893268
Recruitment Status : Completed
First Posted : July 8, 2013
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This prospective, observational study will assess the effectiveness and safety of Avastin (bevacizumab) as 1st line therapy in elderly patients with advanced non-squamous non-small cell lung cancer in clinical practice. Therapy with Avastin and standard chemotherapy will be administered according to the treating physician. Data will be collected for approximately 4 years.

Condition or disease
Non-Squamous Non-Small Cell Lung Cancer

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Study Type : Observational
Actual Enrollment : 279 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Therapeutic Strategies Including Avastin as 1st Line Therapy in Elderly Patients Suffering From Advanced (IIIB/IV Stage) Non-squamous Non-small Cell Lung Cancer, in Routine Clinical Practice.
Actual Study Start Date : July 25, 2013
Actual Primary Completion Date : March 20, 2018
Actual Study Completion Date : March 20, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Group/Cohort
Cohort



Primary Outcome Measures :
  1. Proportion of patients treated with a chemotherapy in combination with Avastin including description of chemotherapy regimens and management of Avastin treatment [ Time Frame: Approximately 4 years ]

Secondary Outcome Measures :
  1. Characteristics of patients with advanced non-squamous non-small cell lung cancer [ Time Frame: Approximately 4 years ]
  2. Tumor characteristics of patients with advanced non-squamous non-small cell lung cancer [ Time Frame: Approximately 4 years ]
  3. Progression-free survival [ Time Frame: Approximately 4 years ]
  4. Overall survival [ Time Frame: Approximately 4 years ]
  5. Quality of Life [ Time Frame: Approximately 4 years ]
  6. Safety: Incidence of adverse events [ Time Frame: Approximately 4 years ]
  7. Reasons of non-use of Avastin as first-line therapy [ Time Frame: Approximately 4 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients aged over 65 years with non-squamous non-small cell lung cancer
Criteria

Inclusion Criteria:

  • Adult patients, >= 65 years of age
  • Diagnosis of advanced non squamous Non-Small Cell Lung Carcinoma (nsNSCLC, stage IIIB or IV) for whom the physician has decided to initiate a treatment with Avastin combined with chemotherapy as 1st line therapy
  • Having received oral and written information about the study, and having signed a written consent form

Exclusion Criteria:

  • Participation in a cancer clinical trial with an investigational medicinal product other than this study
  • Patient previously treated with Avastin
  • Patient under supervision or guardianship

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01893268


  Show 88 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01893268     History of Changes
Other Study ID Numbers: ML28621
First Posted: July 8, 2013    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors