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

NCT ID: NCT03008694

Last Updated: 2017-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2019-01-31

Brief Summary

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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

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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

Conditions

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Oral Cancer Radiotherapy; Complications

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

PET/CT

Group Type EXPERIMENTAL

PET/CT

Intervention Type DEVICE

pet/ct is used as radiotherapy simulation

Interventions

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PET/CT

pet/ct is used as radiotherapy simulation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhongnan Hospital

OTHER

Sponsor Role lead

Responsible Party

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yahua zhong

Director,oncology , Principal Investigator, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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ZhongnanH

Identifier Type: -

Identifier Source: org_study_id

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