Cetuximab in Neoadjuvant Treatment of Non-Resectable Colorectal Liver Metastases (CELIM)
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ClinicalTrials.gov Identifier: NCT00153998 |
Recruitment Status :
Completed
First Posted : September 12, 2005
Last Update Posted : February 27, 2009
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Tracking Information | |||||||
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First Submitted Date ICMJE | September 8, 2005 | ||||||
First Posted Date ICMJE | September 12, 2005 | ||||||
Last Update Posted Date | February 27, 2009 | ||||||
Study Start Date ICMJE | November 2004 | ||||||
Actual Primary Completion Date | March 2008 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Tumor response, defined as partial and complete response according to RECIST (Response Evaluation Criteria in Solid Tumors) - criteria in the intention-to-treat [ITT-] population | ||||||
Original Primary Outcome Measures ICMJE |
Tumor response, defined as partial and complete response according to RECIST- criteria in the intention-to-treat [ITT-] population | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Cetuximab in Neoadjuvant Treatment of Non-Resectable Colorectal Liver Metastases (CELIM) | ||||||
Official Title ICMJE | Open, Randomized, Multicenter, Randomized Phase II Trial Comparing the Combination of Cetuximab With Oxaliplatin/5-FU/FA Versus the Combination of Cetuximab With Irinotecan/5-FU/FA as Neoadjuvant Treatment in Patients With Non-Resectable Colorectal Liver Metastases | ||||||
Brief Summary | General Objectives:
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Detailed Description | Patients with liver metastasis will be screened for this study. Eligible patients will complete the pretreatment evaluation including an abdominal CT scan that will be presented to the local surgeon and the radiologist for proving of resectability of hepatic lesions. Additionally, CT scans will be reviewed by three reference surgeons. In case of non-resectability, as defined above, CT- or ultrasound- guided biopsy of one of the liver metastases will be performed, unless biopsy material is available from prior biopsy of one of the liver metastases. Instead of an ultrasound-guided biopsy, a CT-guided biopsy may be performed. Formalin-fixed, paraffin embedded metastatic tissue will be sent to reference laboratory (Prof. Störkel, Wuppertal) for immunohistochemical analysis of EGFR- expression. Additionally tissue will be stored in "RNA later" for gene expression analysis if agreed by the patient. Additionally, the primary tumor will be collected and sent to the reference laboratory for analysis of EGFR- expression (if agreement of the patient exists). Patients will be randomized to a combination of: Cetuximab/FOLFIRI (irinotecan/5-FU/FA) or Cetuximab/FOLFOX6 (oxaliplatin/5-FU/FA) All patients receive a four month treatment (eight cycles) of the allocated treatment. Resection is planned after completion of neoadjuvant treatment and should be performed between 4 and 6 weeks after the last dose of chemotherapy. Probes of the resected material (in liquid nitrogen and paraffin embedded material will be collected). If a resection is not possible after eight administrations of chemotherapy, chemotherapy will be continued until tumor progression (maximal duration of treatment 2 years) and the patient will be evaluated for a potential resection every two months. After resection, postoperative treatment is planned for 3 months (6 cycles). Treatment start is planned between 4 and 8 weeks after the operation. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
135 | ||||||
Original Enrollment ICMJE | Same as current | ||||||
Study Completion Date ICMJE | Not Provided | ||||||
Actual Primary Completion Date | March 2008 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Austria, Germany | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00153998 | ||||||
Other Study ID Numbers ICMJE | CELIM | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Current Responsible Party | Prof. Dr. Claus-Henning Köhne, now: Klinikum Oldenburg gGmbH | ||||||
Original Responsible Party | Not Provided | ||||||
Current Study Sponsor ICMJE | Technische Universität Dresden | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Technische Universität Dresden | ||||||
Verification Date | April 2007 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |