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Main
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Note: This record shows only the 20 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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15 April 2013 |
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Main ID: |
NCT00199654 |
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Date of registration:
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14/09/2005 |
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Primary sponsor: |
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Public title:
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Positron Emission Tomography (PET) Interest in the Follow Up of Colorectal Cancer Stage II and III
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Scientific title:
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PET Interest in the Follow Up of Colorectal Cancer Stage II and III: Phase III Randomised Study |
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Date of first enrolment:
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February 2004 |
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Target sample size:
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376 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00199654 |
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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, Masking: Open Label, Primary Purpose: Diagnostic
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Countries of recruitment
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France
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Contacts
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Name:
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Nicole TUBIANA-MATHIEU, 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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University Hospital, Limoges |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Signed and dated written informed consent
- Confirmed stage II or III (TNM)
- Patient with curative surgery for colorectal adenocarcinoma
- Total digestive endoscopy prior or post surgery.
- Age > 18 years old
- Normal liver ultrasound and chest X-ray or thoraco-abdomino pelvic computed
tomography (CT) scan.
- In fertile women, efficient contraception or postmenopausal patient (amenorrhea for
at least 1 year)
Exclusion Criteria:
- Serious concomitant pathology
- Uncontrolled diabetes with a classical treatment (glycaemia >1.4 g/l)
- Other malignant tumour within the last 5 years (except for curatively treated
basocellular carcinoma of the skin or in situ cervical carcinoma).
- Uncontrolled infection
- Women who are pregnant or lactating
- Inability to understand informed consent
- Psychological or geographic impossibility to follow up for three years.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Colorectal Cancer
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Intervention(s)
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Procedure: PET
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Primary Outcome(s)
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Time to colorectal cancer relapse
[Time Frame: No]
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Secondary Outcome(s)
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Comparison of the medical cost in the two detection strategies
[Time Frame: No]
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Evaluation of overall survival in the two groups
[Time Frame: after curative resection of colorectal cancer stage II or III]
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Evaluation of the rate of curative surgery
[Time Frame: after relapse]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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