Effect of FDG-PET/CT for Simulation and Radiation Treatment Planning in Oral Cancer Patients

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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

, ,

Administrative Informations

NCT ID

NCT03008694

Organization ID

ZhongnanH

Responsible Party

Principal Investigator

Study Sponsor

Zhongnan Hospital

Study Sponsor

, ,

Verification Date

December 2016