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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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19 February 2015 |
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Main ID: |
NCT00309530 |
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Date of registration:
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31/03/2006 |
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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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Randomized Study on Adjuvant Chemotherapy and Adjuvant Chemo-Immunotherapy in Colon Carcinoma Dukes C
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Scientific title:
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A Prospectively Randomized Phase III Study on Adjuvant Chemotherapy and Adjuvant Chemo-Immunotherapy in Patients With Operated Colon Carcinoma Dukes C (Stage III; T1-4, N1-30, M0). |
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Date of first enrolment:
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October 1990 |
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Target sample size:
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598 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00309530 |
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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: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Austria
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Contacts
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Name:
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Raimund Jakesz, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Austrian Breast & Colorectal Cancer Study Group |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with histologically verified, curatively operated colon carcinoma Stage III
(R0, T1-4, N1-3, M0)
- Age: less than 80 years
- WHO Performace Status > 2
- Adequate bone marrow reserve
- Informed consent
Exclusion Criteria:
- Rectal cancer
- R1, R2, carcinosis peritonei
- Start of chemo- or chemo-immunotherapy > 42 days postop; other adjuvant radiotherapy,
chemotherapy or immunotherapy
- Serious concomitant disease, in particular chronically inflammatory large intestine,
cardiopathic disease, malignant second carcinoma
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Colon Cancer Stage III
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Intervention(s)
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Drug: 5-fluorouracil, levamisol, interferon
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Primary Outcome(s)
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Recurrence-free survival
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Overall survival
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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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