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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT01348256 |
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Date of registration:
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03/05/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study With Dendritic Cell Immunotherapy in Resected Hepatic Metastasis of Colorectal Carcinoma
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Scientific title:
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Randomized Phase II Study With Dendritic Cell Immunotherapy in Patients With Resected Hepatic Metastasis of Colorectal Carcinoma |
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Date of first enrolment:
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November 2010 |
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Target sample size:
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58 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT01348256 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Spain
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Contacts
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Name:
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Ignacio Melero, MD, PHD |
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Address:
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Telephone:
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+34 948 255 400 |
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Email:
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imelero@unav.es |
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Affiliation:
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Name:
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Ignacio Melero, MDPhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Navarra |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Age over 18 years.
2. Confirmed diagnosis of colorectal cancer with hepatic metastasis, amenable for
surgical treatment.
3. Capacity of understanding and signing the informed consent and to undergo the study
procedures
4. Availability of tumor tissue, for maturing dendritic cells
5. Adequate renal, hepatic and bone marrow function
Exclusion Criteria:
1. Clinically relevant diseases or infections.
2. Concurrent participation in other clinical trial or administration or other
antitumoral treatment
3. Concurrent cancer, with the exceptions allowed by the principal investigator (PI).
4. Pregnant or breast feeding women
5. Immunosuppressant treatment
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Colorectal Carcinoma
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Hepatic Metastasis
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Intervention(s)
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Drug: Dendritic cells vaccine
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Primary Outcome(s)
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Progression Free survival
[Time Frame: Progression free survival at 2 years]
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Secondary Outcome(s)
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Overall survival
[Time Frame: 2 years]
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Secondary ID(s)
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2008-007795-23
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CD-2009-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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