Phase II Study Evaluating Strategies of Lung Surveillance of Patients Operated of High Grade Soft Tissue Sarcoma
NCT ID: NCT01612481
Last Updated: 2016-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
11 participants
INTERVENTIONAL
2012-04-30
2015-10-31
Brief Summary
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Detailed Description
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Our study will help rationalise surveillance of soft tissue sarcoma and standardize medical practices.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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chest radiography
clinical exam + chest radiography every 3 months during 2 years and every 6 months during 1 year
chest radiography
surveillance by radiography of chest every 3 months the first 2 years then every 6 month the third, forth and fifth years
chest CT
clinical exam + Chest CT every 3 months during 2 years and every 6 months during 1 year
chest CT
surveillance by CT of chest every 3 months the first 2 years then every 6 month the third, forth and fifth years
Interventions
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chest radiography
surveillance by radiography of chest every 3 months the first 2 years then every 6 month the third, forth and fifth years
chest CT
surveillance by CT of chest every 3 months the first 2 years then every 6 month the third, forth and fifth years
Eligibility Criteria
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Inclusion Criteria
* tumor size \> 5 cm (SBR grade 2) or whatever size (SBR grade 3)
* complete excision (R0 or R1)
* no metastasis (checked by spiral chest CT)
* social security covered
* informed signed consent
Exclusion Criteria
* GIST
* other malignant tumor
* patients over 70, or for whom thoracic surgery is excluded
* pneumoconiosis or known system disease
* breast feeding or pregnant woman
* patient unable to undergo trail medical follow up for geographic, social or psychological reasons
18 Years
70 Years
ALL
No
Sponsors
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Centre Oscar Lambret
OTHER
Responsible Party
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Principal Investigators
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Nicolas PENEL, MD
Role: PRINCIPAL_INVESTIGATOR
Oscar Lambret Center
Locations
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Centre Georges François Leclerc
Dijon, , France
Oscar Lambret Center
Lille, , France
Léon BERARD Center
Lyon, , France
Countries
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Other Identifiers
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CASSANDRE - 1108
Identifier Type: -
Identifier Source: org_study_id
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