Status:
TERMINATED
Application of Medical Imaging Procedures in Surgery Implanting in Cancerology With the Aim to Reduce Invasive Acts
Lead Sponsor:
Centre Leon Berard
Collaborating Sponsors:
French Academic Institution, Financial support: PHRC 2007
Conditions:
Upper Digestive Tract Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Aero digestive Cancer patients treated by external head and neck radiotherapy and/or by curie-therapy and/or mandible reconstruction by microanastomosed fibula flaps. The purpose of the study is to In...
Detailed Description
* Investigate the accuracy of inserting implants in the vertical way and in angulation, on irradiated native mandible or on microanastomosed fibula flaps * Investigate the accuracy of inserting implan...
Eligibility Criteria
Inclusion
- age over 18
- Performance status over 70
- Histological evidence of upper digestive tract cancer
- History of cranial / facial radiotherapy or brachytherapy and/or microvascular fibula transfer.
- Bone volume sufficient to support an implant.
- Mandatory affiliation with a social security system
- Written, voluntary, informed consent
Exclusion
- Patient with evolutive malignant disease
- Contraindication to general anesthesia
- Concurrent disease contra-indicating implant surgery (risk of infectious endocarditis, uncontrolled diabetes, HIV, evolutive neoplasia…)
- Patient enrolled in another clinical trial including chemotherapy
- Pregnant or lactating woman
- Anticipation of an impossible follow-up
- Patient deprived of freedom
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00925509
Start Date
September 1 2007
End Date
December 1 2011
Last Update
June 22 2011
Active Locations (4)
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1
Centre Léon Bérard Service de Chirurgie-Stomatologie
Lyon, Cedex 08, France, 69373
2
CHU Hôtel-Dieu Service d'Odontologie
Clermont-Ferrand, France, 63 000
3
Hospices Civils de Lyon Service de Consultations et Traitements Dentaires
Lyon, France, 69007
4
Centre Hospitalier Lyon Sud Service de Stomatologie et Chirurgie Maxillo-Faciale
Pierre-Bénite, France, 69495