An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer (RELEVANT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01697449
First received: September 28, 2012
Last updated: September 15, 2015
Last verified: September 2015
  Purpose
This prospective observational study will evaluate the safety and efficacy of Avastin (bevacizumab) in patients with metastatic colorectal cancer. Data will be collected from patients receiving Avastin in combination with chemotherapy according to registered indication in routine clinical practice.

Condition
Colorectal Cancer

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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants With At Least One Adverse Event (AE) [ Time Frame: Up to 65 months ] [ Designated as safety issue: No ]
    An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.


Secondary Outcome Measures:
  • Percentage of Participants With Clinical Benefit of Complete Response [CR], Partial Response [PR] or Stable Disease [SD] Per Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to 65 months ] [ Designated as safety issue: No ]
    Per RECIST, CR was defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR was defined as at least a 30 percentage (%) decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter; SD for target lesions was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started and SD for non-target lesions defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and nontarget lesions) or the unequivocal progression of existing non-target lesions.

  • Percentage of Participants Who Were Resectable Postbaseline Among the Participants Who Were Unresectable at Baseline [ Time Frame: Up to 65 months ] [ Designated as safety issue: No ]
  • Percentage of Participants With Disease Progression or Death [ Time Frame: Up to 65 months ] [ Designated as safety issue: No ]
    Per RECIST, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and nontarget lesions) or the unequivocal progression of existing non-target lesions.

  • Progression Free Survival (PFS) [ Time Frame: Up to 65 months ] [ Designated as safety issue: No ]
    PFS was defined as the time from the date of informed consent until the date when the participant had progression of disease or died due to any cause. Participants who left the study for reasons other than progression of the disease were censored at the time of their last tumor assessment. Per RECIST, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions.


Enrollment: 191
Study Start Date: March 2009
Study Completion Date: August 2014
Primary Completion Date: August 2014 (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 metastatic colorectal cancer initiated on Avastin in combination with chemotherapy
Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Metastatic colorectal cancer
  • Prescribed to receive Avastin according to registered indication

Exclusion Criteria:

  • Patients not eligible for Avastin treatment according to the Summary of Product Characteristics
  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: NCT01697449

Locations
Serbia
Belgrade, Serbia, 11000
Belgrade, Serbia, 11080
Kragujevac, Serbia, 34000
NIS, Serbia, 18000
Sremska Kamenica, Serbia, 21204
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: NCT01697449     History of Changes
Other Study ID Numbers: ML21889 
Study First Received: September 28, 2012
Results First Received: September 15, 2015
Last Updated: September 15, 2015
Health Authority: Serbia: Medicines and Medical Devices Agency

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 February 04, 2016