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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: |
NCT03113318 |
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Date of registration:
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10/04/2017 |
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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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Mediastinal Lymph Node Dissection in Conjunction With Pulmonary Metastasectomy From Colorectal Cancer
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Scientific title:
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Total Mediastinal Lymph Node Dissection in Pulmonary Metastasectomy From Colorectal Cancer - a Randomized, Controlled Trial |
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Date of first enrolment:
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October 2015 |
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Target sample size:
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200 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03113318 |
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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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N/A
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Kåre Hornbech, MD |
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Address:
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Telephone:
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+4535451212 |
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Email:
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kaare.hornbech.01@regionh.dk |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age > 18 years
- Able to give informed consent
- Willing to be randomized
Exclusion Criteria:
- Previous mediastinal lymphadenectomy
- Previous pulmonary metastasectomy
- Evidence of other metastasetic disease
- Primary tumor is not under control
- Five metastases or more
- If final histologic examination of the resected lung lesion(s) reveals other histology
than colorectal metastasis
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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Neoplasm Metastasis
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Lung Neoplasms
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Colorectal Cancer
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Intervention(s)
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Procedure: Total mediastinal lymph node dissection and pulmonary metastasectomy
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Procedure: Only pulmonary metastasectomy
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Primary Outcome(s)
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5-year overall survival
[Time Frame: 7-8 years]
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Secondary Outcome(s)
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1-, 3-, 5-year disease free survival
[Time Frame: 7-8 years]
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1-year overall survival
[Time Frame: 3-4 years]
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3-year overall survival
[Time Frame: 4-5 years]
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Number of lymph nodes removed
[Time Frame: 2-3 years]
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30- day morbidity
[Time Frame: 2-3 years]
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30-day mortality
[Time Frame: 2-3 years]
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Secondary ID(s)
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Khornbech
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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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