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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03008694
Recruitment Status : Unknown
Verified December 2016 by yahua zhong, Zhongnan Hospital.
Recruitment status was:  Not yet recruiting
First Posted : January 2, 2017
Last Update Posted : January 2, 2017
Information provided by (Responsible Party):
yahua zhong, Zhongnan Hospital

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

Condition or disease Intervention/treatment Phase
Oral Cancer Radiotherapy; Complications Device: PET/CT Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phrase II Single Arm Study of Effect of FDG-PET/CT for Simulation and Radiation Treatment Planning in Oral
Study Start Date : January 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oral Cancer

Arm Intervention/treatment
Experimental: 1
Device: PET/CT
pet/ct is used as radiotherapy simulation

Primary Outcome Measures :
  1. progress free survival [ Time Frame: baseline to 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Responsible Party: yahua zhong, Director,oncology , Principal Investigator, Clinical Professor, Zhongnan Hospital Identifier: NCT03008694    
Other Study ID Numbers: ZhongnanH
First Posted: January 2, 2017    Key Record Dates
Last Update Posted: January 2, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by yahua zhong, Zhongnan Hospital:
Additional relevant MeSH terms:
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Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases