Brief Title
Effect of FDG-PET/CT for Simulation and Radiation Treatment Planning in Oral Cancer Patients
Official Title
Phrase II Single Arm Study of Effect of FDG-PET/CT for Simulation and Radiation Treatment Planning in Oral
Brief Summary
This study evaluates the effect of FDG-PET/CT for Simulation and Radiation Treatment Planning in oral Cancer patients. Progress-free survival (PFS) will be compared with historical control as defined in the protocol
Detailed Description
Radiotherapy improves local control and overall survival for oral cavity cancer patients after surgery. However, limited locoregional control remains a key issue in the management of oral cavity carcinomas. Appropriate target selection is a key issue in the radiotherapy of oral cavity cancer. The purpose of this study is to determine the locoregional control in PET/CT based radiotherapy treatment planning in the treatment of oral cancer
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
progress free survival
Condition
Oral Cancer
Intervention
PET/CT
Study Arms / Comparison Groups
1
Description: PET/CT
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
100
Start Date
January 2017
Completion Date
January 2019
Primary Completion Date
December 2018
Eligibility Criteria
Inclusion Criteria: - Histologically confirmed oral squamous-cell carcinoma - Age > 17 years - Signed informed consent - ECOG Performance status 0-2 - Must be able to start RT within 4 weeks after PET/CT simulation Exclusion Criteria: - stage IV disease diagnosed before acquisition of staging PET/CT - prior radiotherapy to oral and neck - Unable to understand study participation - Claustrophobia - pregnant or breast feeding mothers
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Administrative Informations
NCT ID
NCT03008694
Organization ID
ZhongnanH
Responsible Party
Principal Investigator
Study Sponsor
Zhongnan Hospital
Study Sponsor
, ,
Verification Date
December 2016