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An Observational Study of Avastin in Participants With Metastatic Colorectal Cancer (KORALLE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01775644
First received: January 23, 2013
Last updated: June 17, 2017
Last verified: June 2017
  Purpose
This observational multicenter study will evaluate the differences in progression-free survival defined in specific subgroups of participants with metastatic colorectal cancer receiving bevacizumab (Avastin). Further, safety and efficacy in daily routine will be assessed.

Condition Intervention
Colorectal Cancer Drug: Bevacizumab

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Avastin ® First Line and Where Applicable Beyond First Progression With Metastatic Colorectal Carcinoma

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Median Progression-Free Survival Time in Defined Participant Subgroups as Assessed by Response Evaluation Criteria In Solid Tumors (RECIST) [ Time Frame: Baseline up to 5 years ]

Secondary Outcome Measures:
  • Percentage of Participants by Prognostic Factors [ Time Frame: Baseline up to 5 years ]
  • Percentage of Participants by Carcinoembryonic Antigen Tumor Marker [ Time Frame: Baseline ]
  • Percentage of Participants by Cancer Antigen 19-9 Tumor Marker [ Time Frame: Baseline ]
  • Percentage of Participants by Eastern Cooperative Oncology Group (ECOG) Performance Status [ Time Frame: Baseline ]
  • Percentage of Participants by Comorbidity Index as per Carlson Method [ Time Frame: Baseline ]
  • Percentage of Participants by RAS Mutation Status [ Time Frame: Baseline ]
  • Percentage of Participants by Cancer Metastasation Status [ Time Frame: Baseline ]
  • Percentage of Participants According to Previous Treatment Regimen of Bevacizumab [ Time Frame: Baseline ]
  • Progression-Free Survival as Assessed by RECIST (Overall) [ Time Frame: Baseline up to 5 years ]
  • Overall Survival in Daily Routine Practice [ Time Frame: Baseline up to 5 years ]
  • Overall Survival in Defined Participant Subgroups in Daily Routine Practice [ Time Frame: Baseline up to 5 years ]
  • Percentage of Participants Showing Overall Response in Daily Routine Practice as Assessed by RECIST [ Time Frame: Baseline up to 5 years ]
  • Number of Treatment Application Schemes of Bevacizumab Daily Routine Practice [ Time Frame: Baseline up to 5 years ]
  • Number of Participants With Adverse Event [ Time Frame: Baseline up to 5 years ]
  • Number of Participants With Reason for Bevacizumab Treatment Modifications and Discontinuation in Defined Participant Subgroups [ Time Frame: Baseline up to 5 years ]
  • Total Cumulative Therapy Dose of Bevacizumab [ Time Frame: Baseline up to 5 years ]
  • Percentage of Participants With Treatment Success [ Time Frame: Baseline up to 5 years ]
  • Percentage of Participants With Resection [ Time Frame: Baseline up to 5 years ]
  • Number of Physicians Satisfied With Treatment [ Time Frame: Baseline up to 5 years ]
  • Percentage of Participants Without Resection by Reason [ Time Frame: Baseline up to 5 years ]
  • Percentage of Participants With Follow-Up therapy [ Time Frame: Baseline up to 5 years ]
  • Percentage of Participants in Defined Participant Subgroups Showing Overall Response in Daily Routine Practice as Assessed by RECIST [ Time Frame: Baseline up to 5 years ]

Enrollment: 3003
Actual Study Start Date: December 17, 2012
Estimated Study Completion Date: April 30, 2018
Estimated Primary Completion Date: April 30, 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Metastatic Colorectal Cancer Participants
Administration of treatment will be as used in normal daily routine under local labelling in 4 subgroups- participants with liver and/or lung metastases, potentially resectable after a response to a systemic therapy and clinically operable; participants with tumor related symptoms, risks for complications or fast progression for whom quick proliferation control is needed; "asymptomatic" participants (indolent tumor) without the option of a metastases resection (no pressure for remission) for whom the aim of the therapy is proliferation control and participants without classification.
Drug: Bevacizumab
Administration of treatment will be as used in normal daily routine under local labeling.
Other Name: Avastin

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants with metastatic colorectal cancer
Criteria

Inclusion Criteria:

  • Participants with metastatic colorectal cancer where physician has decided to give a first-line, fluoro-pyrimidine-based combination therapy with bevacizumab according to Summary of Product Characteristics (SmPC)

Exclusion Criteria:

  • Contraindications for bevacizumab according to SmPC
  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: NCT01775644

Locations
Germany
Klinik für Tumorbiologie Klinik für Intern. Onkologie
Freiburg, Germany, 79106
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01775644     History of Changes
Other Study ID Numbers: ML28120
Study First Received: January 23, 2013
Last Updated: June 17, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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 24, 2017