Trial document

This study has been imported from without additional data checks.
drksid header


Trial Description

start of 1:1-Block title


An Open Label, Single-arm, Phase II Study to Evaluate the Efficacy and the Feasibility of Bevacizumab (Avastin) Based on a FOLFOXIRI Regimen Until Progression in Patients With Previously Untreated Metastatic Colorectal Carcinoma(OPAL-Study)

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym


end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial


end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

This single arm study will assess progression-free survival, feasibility of use and safety
of Avastin in combination with 5-FU/FA, oxaliplatin and irinotecan (FOLFOXIRI) as first line
treatment in patients with metastatic colorectal cancer. Patients will receive up to 12
bi-weekly cycles of Avastin (5mg/kg iv) in combination with this standard neoadjuvant
chemotherapy regimen followed by up to 40 bi-weekly cycles with Avastin plus 5-FU/FA. The
anticipated time on study treatment is until disease progression, and the target sample size
is <100 individuals.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language


end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00002231
  •   2014/05/13
  •   2009/07/06
  •   no
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   2008-001180-11 
  •   NCT00940303  (
  •   ML20514  (Hoffmann-La Roche)
  •   2008-001180-11 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Colorectal Cancer
  •   C18 -  Malignant neoplasm of colon
  •   C19 -  Malignant neoplasm of rectosigmoid junction
  •   C20 -  Malignant neoplasm of rectum
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Drug: bevacizumab [Avastin]
  •   Drug: oxaliplatin
  •   Drug: irinotecan
  •   Drug: leucovorin
  •   Drug: 5-FU
end of 1:N-Block interventions
start of 1:1-Block design


  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   [---]*
  •   II
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

- Progression-free survival; time frame: assessed every 8 weeks up to week 102, 3-monthly during follow-up

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- Overall survival; proportion of patients achieving R0 resectability; objective response rate (complete response [CR] and partial response [PR]); proportion of patients completing 12 cycles of chemotherapy.; time frame: assessed every 4 weeks up to week 102 and at the end of follow-up period
- Proportion of patients with NCI-CTC grade 3-5 adverse events; adverse events, laboratory parameters, ECOG performance status.; time frame: Throughout study, laboratory analyses every 2 weeks, ECOG assessment every 8 weeks

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

end of 1:n-Block recruitment locations
start of 1:1-Block recruitment


  •   [---]*
  •   2009/06/30
  •   [---]*
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   70   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- adult patients, 18-70 years of age;

- metastatic colorectal cancer scheduled for standard first line chemotherapy;

- at least 1 measurable lesion;

- ECOG performance score of 0 or 1.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

- prior chemotherapy for metastatic colorectal cancer;

- prior (neo)adjuvant chemotherapy/radiotherapy of a non-metastatic malignancy
completed within 6 months prior to study entry;

- concomitant malignancies other CRC;

- history or evidence of CNS disease unrelated to cancer.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses


  • start of 1:1-Block address primary-sponsor
    • Hoffmann-La Roche
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Hoffmann-La Roche
    • Clinical Trials 
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Hoffmann-La Roche
    • Clinical Trials 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state


  •   Recruiting complete, follow-up complete
  •   2014/02/01
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
The parameters in and DRKS are not identical. Therefore the data import from required adjustments. For full details please see the DRKS FAQs .
  •   3
  •   2014/04/10
* This entry means the parameter is not applicable or has not been set.