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

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ClinicalTrials.gov Identifier: NCT01775644
Recruitment Status : Completed
First Posted : January 25, 2013
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date January 23, 2013
First Posted Date January 25, 2013
Last Update Posted Date June 13, 2019
Actual Study Start Date December 17, 2012
Actual Primary Completion Date May 10, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 17, 2017)
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 ]
Original Primary Outcome Measures
 (submitted: January 23, 2013)
Differences in progression-free survival of patient subgroups [ Time Frame: 5 years ]
Change History Complete list of historical versions of study NCT01775644 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 17, 2017)
  • 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 ]
Original Secondary Outcome Measures
 (submitted: January 23, 2013)
  • Clinical/demographic patient characteristics at initiation of treatment [ Time Frame: 5 years ]
  • Progression-free survival in daily routine [ Time Frame: 5 years ]
  • Overall response in daily routine [ Time Frame: 5 years ]
  • Response rate in daily routine [ Time Frame: 5 years ]
  • Treatment schemes in daily routine [ Time Frame: 5 years ]
  • Safety: incidence of adverse events [ Time Frame: 5 years ]
  • Reason for treatment modifications/discontinuation [ Time Frame: 5 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title An Observational Study of Avastin in Participants With Metastatic Colorectal Cancer (KORALLE)
Official Title Avastin ® First Line and Where Applicable Beyond First Progression With Metastatic Colorectal Carcinoma
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Participants with metastatic colorectal cancer
Condition Colorectal Cancer
Intervention Drug: Bevacizumab
Administration of treatment will be as used in normal daily routine under local labeling.
Other Name: Avastin
Study Groups/Cohorts 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.
Intervention: Drug: Bevacizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 17, 2017)
3003
Original Estimated Enrollment
 (submitted: January 23, 2013)
3000
Actual Study Completion Date May 10, 2019
Actual Primary Completion Date May 10, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries Germany
 
Administrative Information
NCT Number NCT01775644
Other Study ID Numbers ML28120
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor Hoffmann-La Roche
Collaborators Not Provided
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date June 2019