Trial of Adaptive 18F-FDG-PET Biological Intensity-modulated Radiotherapy (BG-IMRT) in Patients With Head and Neck Tumor
This study has been completed.
Sponsor:
University Hospital, Ghent
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00406289
First received: November 30, 2006
Last updated: September 3, 2010
Last verified: September 2010
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | November 30, 2006 | ||||
| Last Updated Date | September 3, 2010 | ||||
| Start Date ICMJE | November 2006 | ||||
| Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Tumor recurrences | ||||
| Original Primary Outcome Measures ICMJE |
Tumor recidives | ||||
| Change History | Complete list of historical versions of study NCT00406289 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Trial of Adaptive 18F-FDG-PET Biological Intensity-modulated Radiotherapy (BG-IMRT) in Patients With Head and Neck Tumor | ||||
| Official Title ICMJE | Phase I Trial of Adaptive 18F-FDG-PET Biological Intensity-modulated Radiotherapy (BG-IMRT) With Patients With Head and Neck Tumor | ||||
| Brief Summary | This study will evaluate the feasibility of higher and prolonged dose escalation concentrated in the intra-tumoral regions which are FDG-avid after two weeks of radiotherapy. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Head and Neck Tumor | ||||
| Intervention ICMJE | Procedure: 18F-FDG-PET radiotherapy | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 24 | ||||
| Completion Date | February 2010 | ||||
| Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Belgium | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00406289 | ||||
| Other Study ID Numbers ICMJE | 2006/391 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Wilfried De Neve, University Hospital Ghent | ||||
| Study Sponsor ICMJE | University Hospital, Ghent | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Ghent | ||||
| Verification Date | September 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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