Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00002231

Trial Description

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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)

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Trial Acronym

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URL of the Trial

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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.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00002231
  •   2014/05/13
  •   2009/07/06
  •   no
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Secondary IDs

  •   2008-001180-11 
  •   NCT00940303  (ClinicalTrials.gov)
  •   ML20514  (Hoffmann-La Roche)
  •   2008-001180-11 
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Health Condition or Problem studied

  •   Colorectal Cancer
  •   C18 -  Malignant neoplasm of colon
  •   C19 -  Malignant neoplasm of rectosigmoid junction
  •   C20 -  Malignant neoplasm of rectum
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Interventions/Observational Groups

  •   Drug: bevacizumab [Avastin]
  •   Drug: oxaliplatin
  •   Drug: irinotecan
  •   Drug: leucovorin
  •   Drug: 5-FU
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
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  •   II
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Primary Outcome

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

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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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2009/06/30
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  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   70   Years
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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.

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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.

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Addresses

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    • Hoffmann-La Roche
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    • Hoffmann-La Roche
    • Clinical Trials 
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    • Hoffmann-La Roche
    • Clinical Trials 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up complete
  •   2014/02/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov 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.