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

December 29, 2016 updated by: yahua zhong, Zhongnan Hospital

Phrase II Single Arm Study of Effect of FDG-PET/CT for Simulation and Radiation Treatment Planning in Oral

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
progress free survival
Time Frame: baseline to 2 years
baseline to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhongnan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

January 1, 2019

Study Registration Dates

First Submitted

December 23, 2016

First Submitted That Met QC Criteria

December 29, 2016

First Posted (Estimate)

January 2, 2017

Study Record Updates

Last Update Posted (Estimate)

January 2, 2017

Last Update Submitted That Met QC Criteria

December 29, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZhongnanH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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